Enrofloxacin: what the FDA reviewed for dog products
21 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Enrofloxacin, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Cats; Cats and dogs; Dogs; Dogs and cats.
Products
- Baytril® Soft Chewable Tablets (NADA/ANADA 200-608)
- Baytril™ Antibacterial Injectable Solution (NADA/ANADA 140-913)
- Baytril™ Antibacterial Tablets Baytril™ Taste Tabs™ Antibacterial Tablets (NADA/ANADA 140-441)
- EnroPro™ (NADA/ANADA 200-835)
- EnroPro™ 22.7 (NADA/ANADA 200-764)
- Enrofloxacin (NADA/ANADA 200-697)
- Enrofloxacin (NADA/ANADA 200-708)
- Enrofloxacin (NADA/ANADA 200-737)
- Enrofloxacin Antibacterial Injectable Solution (NADA/ANADA 200-527)
- Enrofloxacin Flavored Tablets (NADA/ANADA 200-551)
- Enrofloxacin Flavored Tablets (NADA/ANADA 200-680)
- Enrofloxacin Flavored Tablets (NADA/ANADA 200-810)
- Enroflox® Chewable Tablets (NADA/ANADA 200-720)
- Enroflox™ Injection for Dogs 2.27% (NADA/ANADA 200-513)
- Zobuxa™ (NADA/ANADA 200-517)
Enrofloxacin NADA 200-697, Original approval, April 05, 2021; sponsor Accord Healthcare, Inc.; species: Dogs; foi_id 10790; FDA PDF
Indication
Management of diseases in dogs associated with bacteria susceptible to enrofloxacin.
Dose regimen
2.5 mg/kg, intramuscular (IM) injection, single dose (initial dose), followed 12 hours later by initiation of enrofloxacin tablet therapy
Enrofloxacin Injectable Solution may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy. The initial Enrofloxacin Injectable administration should be followed 12 hours later by initiation of enrofloxacin tablet therapy.
Extraction notes: Generic ANADA (Accord Healthcare, 2021) referencing Baytril Injectable Solution NADA 140-913. Biowaiver granted based on formulation characteristics; no effectiveness, target animal safety or PK data in the summary.
Enrofloxacin Flavored Tablets NADA 200-551, Original approval, April 19, 2013; sponsor Dechra Veterinary Products LLC; species: Cats and dogs; foi_id 1235; FDA PDF
Indication
Management of diseases associated with bacteria susceptible to enrofloxacin (dogs and cats).
Dose regimen
Dogs 5-20 mg/kg (2.27-9.07 mg/lb); cats 5 mg/kg (2.27 mg/lb), oral, single daily dose or divided into two equal daily doses at twelve hour intervals
Cats: administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two equal daily doses administered at twelve hour intervals. Dogs: administer orally at a rate to provide 5-20 mg/kg (2.27-9.07 mg/lb) of body weight.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | generic 10963 vs RLNAD 10931 (ng/mL)*hour (geometric means); CI 98.9%-103.8% | dogs, 136 mg tablet single oral dose, 20 fasted healthy beagle dogs, two-way crossover, 7-day washout (Table 2; columns: generic mean, RLNAD mean, lower bound, upper bound) | AUC (ng/mL)*hour 10963* 10931* 98.9% 103.8% |
| cmax | generic 2811 vs RLNAD 2785 ng/mL (geometric means); CI 94.5%-107.4% | dogs, 136 mg tablet, fasted, crossover (Table 2) | CMAX (ng/mL) 2811* 2785* 94.5% 107.4% |
| tmax | generic 1.76 vs RLNAD 1.80 hour (arithmetic means) | dogs, 136 mg tablet, fasted, crossover (Table 2) | TMAX (hour) 1.76† 1.80† NA NA |
| auc | generic 22518 vs RLNAD 21575 (ng/mL)*hour (geometric means); CI 100.2%-110.2% | CATS, 22.7 mg tablet single oral dose, 20 fasted mixed breed cats, crossover, 14-day washout (Table 1) | AUC (ng/mL)*hour 22518* 21575* 100.2% 110.2% |
| cmax | generic 2562 vs RLNAD 2345 ng/mL (geometric means); CI 100.9%-119.5% | CATS, 22.7 mg tablet, fasted, crossover (Table 1) | CMAX (ng/mL) 2562* 2345* 100.9% 119.5% |
| tmax | generic 0.84 vs RLNAD 0.88 hour (arithmetic means) | CATS, 22.7 mg tablet, fasted, crossover (Table 1) | TMAX (hour) 0.84† 0.88† NA NA |
Effectiveness
Bioequivalence (not a clinical effectiveness study): randomized, two-way crossover, single-dose, replicate-design blood-level study of generic 136 mg enrofloxacin tablet vs BAYTRIL TASTE TABS 136 mg in fasted healthy beagle dogs, 7-day washout; n = 20; primary endpoint: 90% confidence interval of generic/RLNAD ratio for AUC and CMAX within 80.00%-125.00%; result: Both AUC and CMAX within the prescribed bounds; bioequivalence demonstrated (a parallel study in 20 cats with the 22.7 mg tablet also met the criteria)
The study was conducted as a 2-period, 2-treatment crossover design using 20 dogs with a 7 day washout between periods.
Extraction notes: Generic ANADA (Putney) referencing BAYTRIL TASTE TABS NADA 140-441. New target animal safety and effectiveness data were not required; effectiveness field holds the dog blood-level bioequivalence study. PK rows are Table 1 (cats) and Table 2 (dogs) rows quoted as extracted; asterisk marks geometric means and dagger arithmetic means; CI values are 90% confidence bounds. Dissolution biowaiver granted for 22.7 and 68 mg (dogs) and 68 and 136 mg (cats).
Enrofloxacin NADA 200-708, Original approval, August 02, 2021; sponsor Felix Pharmaceuticals Pvt. Ltd.; species: Dogs; foi_id 11143; FDA PDF
Indication
Management of diseases in dogs associated with bacteria susceptible to enrofloxacin
Dose regimen
2.5 mg/kg, Intramuscular (IM) injection, Single dose (initial dose), Initial IM dose only, followed 12 hours later by initiation of enrofloxacin tablet therapy
Enrofloxacin Injectable Solution may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy. The initial enrofloxacin injectable administration should be followed 12 hours later by initiation of enrofloxacin tablet therapy.
Extraction notes: Generic ANADA approved on a biowaiver (injectable solution with the same active ingredient, concentration and dosage form as the RLNAD Baytril Injectable Solution, NADA 140-913). The summary contains no in vivo bioequivalence, PK, target animal safety, effectiveness or adverse reaction data, so those fields are empty; the validator warning 'no PK, safety or effectiveness content' is expected.
Baytril™ Antibacterial Tablets Baytril™ Taste Tabs™ Antibacterial Tablets NADA 140-441, Supplemental approval, August 03, 1999; sponsor Elanco US Inc.; species: Dogs and cats; foi_id 482; FDA PDF
Indication
Management of diseases in dogs and cats associated with bacteria susceptible to enrofloxacin (unchanged).
Dose regimen
5 – 20 mg/kg (2.27 – 9.07 mg/lb), oral, single daily dose or divided into two equal daily doses at 12 hour intervals, continued for at least 2 – 3 days beyond cessation of clinical signs, to a maximum of 30 days
Administered orally at a rate to provide 5 – 20 mg/kg (2.27 – 9.07 mg/lb) of body weight, either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals.
Extraction notes: 1999 supplemental approval adding a 136 mg Taste Tabs tablet. No safety or effectiveness data were required: 'The approval of the 136 mg tablet does not require safety or effectiveness data as the dosage remains the same as currently approved.' Approval based on manufacturing, dissolution and stability information only.
EnroPro™ 22.7 NADA 200-764, Original approval, December 22, 2023; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs; foi_id 14868; FDA PDF
Indication
Management of diseases in dogs associated with bacteria susceptible to enrofloxacin
Dose regimen
2.5 mg/kg, Intramuscular injection, Single dose (initial dose), Initial IM dose only, followed 12 hours later by initiation of enrofloxacin tablet therapy (dosing table: 1.00 mL for 9.1 kg, 3.00 mL for 27.2 kg)
EnroPro™ 22.7 Injectable Solution may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy.
Extraction notes: Generic ANADA approved on a biowaiver (same active ingredient, concentration and dosage form as the RLNAD Baytril injectable solution 2.27%, NADA 140-913). No in vivo bioequivalence, PK, target animal safety, effectiveness or adverse reaction data in the summary; the validator warning 'no PK, safety or effectiveness content' is expected.
Baytril™ Antibacterial Tablets Baytril™ Taste Tabs™ Antibacterial Tablets NADA 140-441, Original approval, December 27, 1988; sponsor Elanco US Inc.; species: Dogs; foi_id 1987; FDA PDF
Indication
Treatment of dermal infections (wounds and abscesses), respiratory infections (pneumonia, tonsilitis, rhinitis) and urinary cystitis in dogs caused by susceptible strains of E. coli, Klebsiella pneumoniae, Proteus mirabilis and Staphylococcus aureus.
Dose regimen
2.5 mg/kg (1.13 mg/lb), oral (tablet), twice daily, continued for two to three days beyond cessation of clinical signs, to a maximum of ten days
The optimum oral dose of Baytril® (brand of enrofloxacin) Tablets has been established at 2.5 mg/kg (1.13 mg/lb) of body weight administered twice daily.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| tmax | 1 hour (50% of maximum serum concentration within 15 minutes) | 2.5 mg/kg oral, healthy adult dogs (12 dogs in 3 groups of 4; three dose levels, oral and IV) | At the recommended dose of 2.5 mg/kg (1.13 mg/lb) given orally, it reached 50% of its maximum serum concentration within 15 minutes and peak concentration occurred in 1 hour. |
| half-life | greater than 3 hours | oral and intravenous doses (1.25, 2.5, 5.0 mg/kg) | The half-life was greater than three (3) hours with both oral and intravenous doses. |
| bioavailability | approximately 80% | oral tablet vs intravenous | Approximately 80% of the orally administered dose entered the systemic circulation unchanged. |
| clearance | approximately 9 ml/min/kg | same at each dose rate (1.25, 2.5, 5.0 mg/kg) | The body clearance time was the same (approximately 9 ml/min/kg) at each dose rate |
| other | plasma enrofloxacin 0.67 / 0.55 / 0.36 mcg/mL | Table 14 tissue distribution study; single oral dose 2.5 mg/kg; columns are 2.0, 4.0 and 8.0 hours after dosing; n=6 through 2 h, n=4 at 4 h, n=2 at 8 h | Plasma 0.67 0.55 0.36 |
| other | urine enrofloxacin 43.05 / 33.30 / 55.35 mcg/mL | Table 14; single oral dose 2.5 mg/kg; columns are 2.0, 4.0 and 8.0 hours after dosing | Urine 43.05 33.30 55.35 |
| other | liver enrofloxacin 3.02 / 2.21 / 1.36 mcg/g | Table 14; single oral dose 2.5 mg/kg; columns are 2.0, 4.0 and 8.0 hours after dosing; n=2 per interval | Liver 3.02 2.21 1.36 |
| other | skin enrofloxacin 0.66 / 0.80 / 0.48 mcg/g | Table 14; single oral dose 2.5 mg/kg; columns are 2.0, 4.0 and 8.0 hours after dosing; n=2 per interval | Skin 0.66 0.80 0.48 |
Target-animal safety
dose multiples 1X, 3X, 5X; duration 30 days (3 times the labeled duration); animals 16 adult dogs (4 per treatment group plus 4 controls).
M. Kohlenberg of Shawnee Mission, Kansas conducted a study in 16 adult, male and female dogs of various breeds with daily treatments at the use rate of 5 mg/kg/day (2.27 mg/lb/day). 3X use rate and 5X use rate for 30 days or 3 times the labeled duration. Four dogs were included in each treatment group plus 4 controls.
| Finding | Quote |
|---|---|
| No treatment-related adverse effects at 1X, 3X or 5X for 30 days except slight loss of appetite and depression at elevated doses | No treatment related adverse effects were observed in any of the parameters except for slight loss of appetite and depression in the dogs receiving the elevated treatments. |
| Drug tolerance study: 125 mg/kg/day caused vomition, inappetence, depression and death (days 10 and 11) in 2 dogs; 50 mg/kg/day caused infrequent vomition | The 125 mg/kg (56.7 mg/lb) treatment induced vomition, inappetence, depression and death in these 2 dogs with death occurring on Days 10 and 11. |
| Older puppies (19-28.5 weeks) dosed 5, 15 or 25 mg/kg/day for 30 days: lameness at 25 mg/kg and dose-related articular cartilage lesions in all treated groups | Clinical signs of lameness were observed in the 25 mg/kg (11.34 mg/lb) treated group. Histological lesions of the articular cartilage were observed in all treatment groups and the effects were dose related. |
| Rapidly growing large-breed puppies (10-12 weeks) at 10 mg/kg/day for 10-14 days: abnormal foreleg carriage and articular cartilage lesions | This controlled study confirmed this dosage rate can induce abnormal carriage of the foreleg and histological lesions of the articular cartilage in this age of rapidly growing large type breeds of dogs. |
Effectiveness
Pivotal well-controlled, blinded multi-investigator (10 sites) clinical field trial; dogs with dermal, enteric, respiratory or urinary tract infections randomized to enrofloxacin 2.5 mg/kg BID or Tribrissen 26.4 mg/kg SID orally for 5-10 days (positive control); n = 107 enrofloxacin and 78 Tribrissen; primary endpoint: clinical response (pre- vs post-treatment clinical scores) and bacteriological response (pathogen elimination); result: Clinically significant reductions in post-treatment scores with no medically significant difference between groups; pathogen elimination 70% (enrofloxacin) vs 67% (Tribrissen); by organism 80% vs 72%
A total of 107 enrofloxacin and 78 Tribrissen® treated dogs (96 male and 89 female) of various breeds, ages (6 wks to 23 yrs) and weights were included in the study.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| vomition, apparently drug related (clinical field trial safety evaluation, 270 dogs) | 2/270 (0.7%) | Two of the 270 (0.7%) treated with enrofloxacin tablets in the clinical field trials exhibited side effects, which were apparently drug related. These 2 cases of vomition were self-limiting. | |
| vomition, judged probably not drug related | 2 | These observations were classified as mild, self-limiting and consisted of 2 incidents of vomition, 2 of depressed appetite and 2 of either diarrhea or soft stool. | |
| depressed appetite, judged probably not drug related | 2 | These observations were classified as mild, self-limiting and consisted of 2 incidents of vomition, 2 of depressed appetite and 2 of either diarrhea or soft stool. | |
| diarrhea or soft stool, judged probably not drug related | 2 | These observations were classified as mild, self-limiting and consisted of 2 incidents of vomition, 2 of depressed appetite and 2 of either diarrhea or soft stool. | |
| vomiting (pivotal field trial; two cases led to discontinuation) | Vomiting was noted in three enrofloxacin treated dogs, one dog developed diarrhea and one had a decrease in appetite. Two of the vomiting cases resulted in the medication being discontinued and it was judged that the vomiting in these cases was apparently treatment related. |
Extraction notes: Original NADA 140-441 summary (1988). PK from Ling & Baggot 12-dog study (values reported narratively, no Cmax/AUC figures) plus Table 14 tissue/body fluid distribution (rows quoted as extracted; columns are 2.0/4.0/8.0 h after a single 2.5 mg/kg oral dose). Target animal safety: pivotal margin-of-safety study (1X/3X/5X for 30 days) chosen for design; additional findings from drug tolerance and puppy studies included because articular cartilage lesions are the key finding. Effectiveness pivotal field trial n reflects enrolled dogs; 99 enrofloxacin/66 Tribrissen cases assessed for clinical response and 73/48 for bacteriological response. Adverse reaction counts in the pivotal trial are spelled out in words (three, one) so treated left null for that row; control group: no reported side effects in the Tribrissen group.
Enrofloxacin NADA 200-737, Original approval, February 02, 2023; sponsor ZyVet Animal Health, Inc.; species: Dogs and cats; foi_id 13437; FDA PDF
Indication
Management of diseases associated with bacteria susceptible to enrofloxacin, in dogs and cats
Dose regimen
5-20 mg/kg (dogs), Oral, Once daily (or divided into two equal doses at 12-hour intervals), Selection of a dose within the range based on clinical experience, severity of disease and pathogen susceptibility; may be given as a single daily dose or divided into two equal doses at 12-hour intervals; continue at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days. Cats: 5 mg/kg once daily.
Dogs: Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 12292 (ng/mL)*hour (geometric mean, generic) | Dog BE study (Study 20235621): 136 mg generic tablet, single oral dose, fasted intact male beagles, n=18 crossover. Row columns: parameter, generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI | AUC (ng/mL)*hour 12292† 11613† 1.06 1.02 1.10 |
| auc | 11613 (ng/mL)*hour (geometric mean, RLNAD Baytril Taste Tabs) | Dog BE study: 136 mg RLNAD tablet, single oral dose, fasted, n=18 | AUC (ng/mL)*hour 12292† 11613† 1.06 1.02 1.10 |
| cmax | 2913 ng/mL (geometric mean, generic) | Dog BE study: 136 mg generic tablet, single oral dose, fasted, n=18 | CMAX (ng/mL) 2913† 2700† 1.08 1.03 1.13 |
| cmax | 2700 ng/mL (geometric mean, RLNAD) | Dog BE study: 136 mg RLNAD tablet, single oral dose, fasted, n=18 | CMAX (ng/mL) 2913† 2700† 1.08 1.03 1.13 |
| tmax | 2.5 hours (arithmetic mean; SD 0.75), generic | Dog BE study: 136 mg generic tablet, single oral dose, fasted, n=18 | TMAX (hours) (SD)‡ 2.5 (0.75)‡ 2.0 (0.75)‡ NE NE NE |
| tmax | 2.0 hours (arithmetic mean; SD 0.75), RLNAD | Dog BE study: 136 mg RLNAD tablet, single oral dose, fasted, n=18 | TMAX (hours) (SD)‡ 2.5 (0.75)‡ 2.0 (0.75)‡ NE NE NE |
| auc | 14563 (ng/mL)*hour (geometric mean, generic) — CATS | Cat BE study (KFI-113-BF-3620): 22.7 mg generic tablet, single oral dose, fasted neutered male cats, n=18 crossover (RLNAD 14152) | AUC (ng/mL)*hour 14563† 14152† 1.03 0.99 1.07 |
| cmax | 1283 ng/mL (geometric mean, generic) — CATS | Cat BE study: 22.7 mg generic tablet, single oral dose, fasted cats, n=18 (RLNAD 1243) | CMAX (ng/mL) 1283† 1243† 1.03 0.96 1.11 |
Effectiveness
Blood-level bioequivalence study (ANADA; not a clinical effectiveness trial): randomized, masked, two-period, two-sequence, two-treatment, single-dose crossover in fasted healthy intact male dogs (8.5 months to 3 years, 8.52-10.83 kg), 136 mg generic tablet vs 136 mg Baytril Taste Tabs, 7-day washout (Study No. 20235621); n = 18; primary endpoint: CMAX and AUC (time 0 to last quantifiable concentration); bioequivalence if the 90% confidence interval of the geometric mean ratio (generic:RLNAD) for both lies within 0.80-1.25; result: Bioequivalence demonstrated in dogs: AUC ratio 1.06 (90% CI 1.02-1.10), CMAX ratio 1.08 (90% CI 1.03-1.13) (Table II.1). 22.7 mg and 68 mg strengths granted a biowaiver in dogs (all strengths >85% dissolved in 15 minutes).
The laboratory study was conducted as a randomized, masked two-period, two- sequence, two-treatment, single-dose crossover design using 18 dogs with a 7-day washout between periods.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Serious adverse events (dog BE study) | There were no serious adverse events reported during the study. |
Extraction notes: Generic ANADA: effectiveness and target animal safety data were not required; no TAS study in the summary. The effectiveness field holds the pivotal in vivo blood-level bioequivalence study in dogs (labelled as such, not a clinical trial). A parallel BE study in 18 fasted cats (22.7 mg tablets, 14-day washout) is also in the summary; two cat PK rows are included and labelled CATS. Proprietary name in the summary is simply 'Enrofloxacin'. Dose regimen recorded for dogs; cats 5 mg/kg once daily.
Baytril™ Antibacterial Tablets Baytril™ Taste Tabs™ Antibacterial Tablets NADA 140-441, Supplemental approval, February 23, 2001; sponsor Elanco US Inc.; species: Cats and dogs; foi_id 483; FDA PDF
Indication
Management of disease associated with bacteria susceptible to enrofloxacin (cats and dogs).
Dose regimen
Dogs 5-20 mg/kg (2.27 to 9.07 mg/lb); cats 5 mg/kg (2.27 mg/lb), oral, single daily dose or divided into two equal daily doses at 12 hour intervals, cat dose lowered to 5 mg/kg/day due to post-approval reports of retinal toxicity; do not exceed 5 mg/kg/day in cats
Cats: Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. Dogs: Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight.
Target-animal safety
dose multiples 1X, 4X, 10X; duration 21 consecutive days (groups observed for 3 or 5 weeks); animals 32 cats (16 males and 16 females; 4 cats/sex/group).
BAYTRIL was administered orally at 5 mg/kg, 20 mg/kg, and 50 mg/kg of body weight per day for 21 consecutive days. b. Animals: Thirty-two (32) healthy cats (16 males and 16 females) were randomly assigned to four treatment groups of 4 cats/sex/group.
| Finding | Quote |
|---|---|
| Vomiting, salivation and depression at 20 and 50 mg/kg/day | Vomiting, salivation and depression were noted in the 20 and 50 mg/kg/day groups. |
| 5 mg/kg/day: normal ophthalmic exams and ERGs, no retinal histopathology | Cats receiving 5 mg/kg/day of enrofloxacin had normal ophthalmic exams and no abnormalities noted on the electroretinograms (ERGs) throughout the study. |
| 20 mg/kg/day: 2 of 8 cats abnormal ERGs; two other cats with serious fundic lesions (retinal degeneration) | In the 20 mg/kg/day groups, 2 of 8 cats had abnormal findings on ERGs. |
| 50 mg/kg/day: 5 of 8 cats with generalized retinal degeneration; irreversible histopathological retinal changes in all 8 | In the 50 mg/kg/day groups, 5 out of 8 cats had serious fundic lesions consisting of generalized retinal degeneration. |
| Conclusion: 5 mg/kg/day should not be exceeded in cats because higher doses may cause retinal toxicity | It was concluded that a dose of 5 mg/kg/day should not be exceeded in cats as higher doses may cause retinal toxicity. |
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Ocular: mydriasis, retinal degeneration, loss of vision (post-approval reports, cats) | Ocular: Mydriasis, retinal degeneration (retinal atrophy, attenuated retinal vessels, and hyperreflective tapeta have been reported), loss of vision. | ||
| Gastrointestinal: vomiting, anorexia, elevated liver enzymes, diarrhea (post-approval reports) | Gastrointestinal: vomiting, anorexia, elevated liver enzymes, diarrhea | ||
| Neurologic: ataxia, seizures (post-approval reports) | Neurologic: ataxia, seizures | ||
| Behavioral: depression, lethargy, vocalization, aggression (post-approval reports) | Behavioral: depression, lethargy, vocalization, aggression |
Extraction notes: 2001 supplement to a dog/cat application; the only new study is a feline ocular safety study (target_animal_safety records CATS, not dogs: 32 cats at 0, 5, 20 and 50 mg/kg/day = control, 1X, 4X, 10X for 21 days). Dog dose range 5-20 mg/kg unchanged. No new effectiveness data (cross-referenced to earlier summaries). Adverse reactions are voluntary post-approval adverse drug experience reports listed in labeling without rates.
Enrofloxacin Antibacterial Injectable Solution NADA 200-527, Original approval, January 09, 2015; sponsor Dechra Veterinary Products LLC; species: Dogs; foi_id 1217; FDA PDF
Indication
Management of diseases in dogs associated with bacteria susceptible to enrofloxacin.
Dose regimen
2.5 mg/kg, intramuscular injection, single dose, followed by initiation of enrofloxacin tablet therapy
2.5 mg/kg as a single dose, followed by initiation of enrofloxacin tablet therapy
Extraction notes: Generic ANADA (Putney) referencing BAYTRIL Injectable Solution NADA 140-913. Biowaiver granted based on formulation characteristics; CVM did not require effectiveness or target animal safety studies. No study data in the summary. Label warning notes use in cats may result in retinal toxicity.
EnroPro™ NADA 200-835, Original approval, July 20, 2026; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs and cats; foi_id 18678; FDA PDF
Indication
Management of diseases associated with bacteria susceptible to enrofloxacin, in dogs and cats
Dose regimen
5-20 mg/kg (dogs), Oral, Once daily (or divided into two equal doses at 12-hour intervals), Selection of a dose within the range based on clinical experience, severity of disease and pathogen susceptibility; may be given as a single daily dose or divided into two equal doses at 12-hour intervals; continue at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days. Cats: 5 mg/kg once daily.
Dogs: Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 9510.51 (ng/mL)*hour (geometric mean, generic) | Dog BE study (VLL/1124/BE003): 136 mg generic tablet, single oral dose, fasted neutered/spayed beagles 1-3 years, 8-11 kg, n=24 crossover. Row columns: parameter, generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI | AUC (ng/mL)*hour 9510.51† 9251.76† 1.03 0.98 1.07 |
| auc | 9251.76 (ng/mL)*hour (geometric mean, RLNAD Baytril Taste Tabs) | Dog BE study: 136 mg RLNAD tablet, single oral dose, fasted, n=24 | AUC (ng/mL)*hour 9510.51† 9251.76† 1.03 0.98 1.07 |
| cmax | 2223.11 ng/mL (geometric mean, generic) | Dog BE study: 136 mg generic tablet, single oral dose, fasted, n=24 | CMAX (ng/mL) 2223.11† 2330.54† 0.95 0.91 1.00 |
| cmax | 2330.54 ng/mL (geometric mean, RLNAD) | Dog BE study: 136 mg RLNAD tablet, single oral dose, fasted, n=24 | CMAX (ng/mL) 2223.11† 2330.54† 0.95 0.91 1.00 |
| tmax | 1.44 hours (arithmetic mean; SD 0.50), generic | Dog BE study: 136 mg generic tablet, single oral dose, fasted, n=24 | TMAX (hours) (SD)‡ 1.44 (0.50) ‡ 1.33 (0.51 )‡ NE NE NE |
| tmax | 1.33 hours (arithmetic mean; SD 0.51), RLNAD | Dog BE study: 136 mg RLNAD tablet, single oral dose, fasted, n=24 | TMAX (hours) (SD)‡ 1.44 (0.50) ‡ 1.33 (0.51 )‡ NE NE NE |
| auc | 16248.68 (ng/mL)*hour (geometric mean, generic) — CATS | Cat BE study (KFI-108-BF-3122): 22.7 mg generic tablet, single oral dose, fasted domestic short hair cats, n=24 crossover (RLNAD 16114.42) | AUC (ng/mL)*hour 16248.68† 16114.42† 1.01 0.99 1.03 |
| cmax | 1660.21 ng/mL (geometric mean, generic) — CATS | Cat BE study: 22.7 mg generic tablet, single oral dose, fasted cats, n=24 (RLNAD 1665.40) | CMAX (ng/mL) 1660.21† 1665.40† 1.00 0.94 1.06 |
Effectiveness
Blood-level bioequivalence study (ANADA; not a clinical effectiveness trial): randomized, masked, two-period, two-sequence, two-treatment, single-dose crossover in fasted healthy neutered male and spayed female beagle dogs (1-3 years, 8-11 kg), 136 mg generic EnroPro tablet vs 136 mg Baytril Taste Tabs, 14-day washout (Study No. VLL/1124/BE003); n = 24; primary endpoint: CMAX and AUC (time 0 to last quantifiable concentration); bioequivalence if the 90% confidence interval of the geometric mean ratio (generic:RLNAD) for both lies within 0.80-1.25; result: Bioequivalence demonstrated in dogs: AUC ratio 1.03 (90% CI 0.98-1.07), CMAX ratio 0.95 (90% CI 0.91-1.00) (Table 1). 22.7 mg and 68 mg strengths granted a biowaiver in dogs (>85% dissolved in 15 minutes).
The laboratory study was conducted with a randomized, masked, two-period, two- sequence, two-treatment, single-dose crossover design using 24 dogs with a 14-day washout between periods.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Serious adverse events related to test or reference article (dog BE study) | There were no serious adverse events related to the test or reference article reported during the study. |
Extraction notes: Generic ANADA: effectiveness and target animal safety data were not required; no TAS study in the summary. The effectiveness field holds the pivotal in vivo blood-level bioequivalence study in dogs (labelled as such, not a clinical trial). A parallel BE study in 24 fasted cats (22.7 mg tablets, 14-day washout) is also in the summary; two cat PK rows are included and labelled CATS. The dog TMAX row is quoted with the irregular spacing exactly as extracted ('(0.50) ‡', '(0.51 )‡'). Dose regimen recorded for dogs; cats 5 mg/kg once daily.
Baytril® Soft Chewable Tablets NADA 200-608, Original approval, July 30, 2018; sponsor Elanco US Inc.; species: Dogs and cats; foi_id 3893; FDA PDF
Indication
Management of diseases associated with bacteria susceptible to enrofloxacin (dogs and cats).
Dose regimen
Dogs 5-20 mg/kg (2.27 to 9.07 mg/lb), oral (soft chewable tablet), single daily dose or divided into two equal daily doses at 12 hour intervals, continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days; cats 5 mg/kg (2.27 mg/lb)
Dogs: Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | AUCtlast test 15011.54 vs reference 15597.50 hr*ng/mL (geometric means); ratio 0.96; CI 0.91-1.02 | dogs, 136 mg tablet single oral dose, 24 fasted purpose-bred male beagle dogs, two-sequence crossover, 14-day washout (Table II.2; columns: test mean, reference mean, ratio T/R, lower bound, upper bound) | AUCtlast (hr*ng/mL) 15011.54† 15597.50† 0.96 0.91 1.02 |
| cmax | test 2714.0 vs reference 2789.0 ng/mL (geometric means); ratio 0.97; CI 0.93-1.01 | dogs, 136 mg tablet, fasted, crossover (Table II.2) | Cmax (ng/mL) 2714.0† 2789.0† 0.97 0.93 1.01 |
| tmax | test 1.7 vs reference 1.7 hour (arithmetic means) | dogs, 136 mg tablet, fasted, crossover (Table II.2) | Tmax (hour) 1.7‡ 1.7‡ N/A N/A N/A |
| auc | AUCtlast test 22514.2 vs reference 24245.8 hr*ng/mL; ratio 92.9%; CI 88.6%-97.3% | CATS, 22.7 mg tablet single oral dose, 24 purpose-bred neutered male and intact female cats, crossover, 14-day washout (Table II.1) | AUCtlast (hr*ng/mL) 22514.2 24245.8 92.9 88.6 97.3 |
| cmax | test 1724.2 vs reference 2039.2 ng/mL (geometric means); ratio 84.6%; CI 81.4%-87.8% | CATS, 22.7 mg tablet, crossover (Table II.1) | Cmax (ng/mL) 1724.2† 2039.2† 84.6 81.4 87.8 |
| tmax | test 1.71 vs reference 0.96 hour (arithmetic means) | CATS, 22.7 mg tablet, crossover (Table II.1) | Tmax (hour) 1.71‡ 0.96‡ N/A N/A N/A |
Effectiveness
Bioequivalence (not a clinical effectiveness study): randomized, two-way crossover, single-dose blood-level study of generic 136 mg enrofloxacin soft chewable tablet vs Baytril Taste Tabs 136 mg in fasted purpose-bred male beagle dogs, 14-day washout; n = 24; primary endpoint: 90% confidence interval of test/reference ratio for AUCtlast and Cmax within 80.00%-125.00%; result: Both AUC and Cmax within the prescribed bounds; bioequivalence demonstrated; no significant adverse effects (a parallel study in 24 cats with the 22.7 mg tablet also met the criteria)
The study was conducted as a single dose, randomized, two-sequence, cross-over design using 24 dogs with a 14-day washout between periods.
Extraction notes: Generic ANADA (Piedmont Animal Health) for a soft chewable dosage form approved via suitability petition, referencing Baytril Taste Tabs NADA 140-441. New target animal safety and effectiveness data were not required; effectiveness field holds the dog blood-level bioequivalence study. PK rows quoted as extracted from Tables II.1 (cats) and II.2 (dogs); dagger marks geometric means, double dagger arithmetic means; CI values are 90% confidence bounds; note the dog table reports ratio/bounds as fractions and the cat table as percentages. Dissolution biowaiver granted for the 22.7 and 68 mg dog strengths and 68/136 mg cat strengths.
Baytril™ Antibacterial Tablets Baytril™ Taste Tabs™ Antibacterial Tablets NADA 140-441, Supplemental approval, June 06, 1990; sponsor Elanco US Inc.; species: Dogs; foi_id 1725; FDA PDF
Indication
Treatment of dermal infections (wounds and abscesses), respiratory infections and urinary tract infections (cystitis) in dogs caused by susceptible strains of E. coli, Klebsiella pneumoniae, Proteus mirabilis and Staphylococcus aureus; supplement removes the contraindication against use in breeding female dogs.
Dose regimen
2.5 mg/kg (1.13 mg/lb), oral (tablet), twice daily, two to three days beyond cessation of clinical signs to a maximum of ten days
The optimum oral dose of Baytril® (brand of enrofloxacin) Tablets has been established at 2.5 mg/kg (1.13 mg/lb) of body weight administered twice daily.
Target-animal safety
dose multiples 1X, 3X; duration 10 consecutive days at each of 4 stages of reproduction (prior to breeding, early pregnancy, late pregnancy, lactation); animals 15 adult female Beagle dogs (four controls, 5 at 5 mg/kg/day, 6 at 15 mg/kg/day).
A. Stuke and J. Magerkurth of Topeka, Kansas conducted a reproductive safety study in 15 adult female Beagle breed dogs with the 22.7 mg enrofloxacin tablet. The purpose of this study was to evaluate libido and safety in female breeding dogs following multiple treatments with the approved market tablet formulation. Before treatment the dogs were randomly assigned to one of 3 groups. Four dogs served as the non-treated controls, 5 received treatments orally of 2.5 mg/kg (1.13 mg/lb) twice daily for a total of 5 mg/kg (2.27 mg/lb) per day and 6 were treated orally with 7.5 mg/kg (3.40 mg/lb) twice daily for a total of 15 mg/kg (6.80 mg/lb) per day.
| Finding | Quote |
|---|---|
| All reproductive parameters within normal ranges and comparable to historical controls | As shown in the table all the parameters measured were within normal anticipated ranges and are comparable to the historical control results. |
| No adverse effects on reproductive parameters and no clinical signs of toxicosis at up to 3X the labeled rate for 10 days at 4 reproductive stages | The study concluded that no adverse effects occurred upon reproductive parameters nor were there any clinical signs of toxicosis when female breeding dogs are treated with enrofloxacin tablets at doses as high as 3 times the labeled rate for 10 consecutive days at 4 critical stages of reproduction: 30 to 0 days prior to breeding, early pregnancy (between the 10th and 30th days), late pregnancy (between the 40th and 60th days) and during lactation (the first 28 days). |
Extraction notes: 1990 supplement whose sole new study is the female breeding dog reproductive safety study (Table I reproductive performance compared with 1987 historical controls). Effectiveness cross-referenced to the original NADA summary (54 FR 3444); no new effectiveness data. Indication quote uses the 'Effect of Supplement' sentence because the indication text in this summary is interrupted by a footnote about Klebsiella; the summary's typo 'contradiction' (for contraindication) is preserved.
Baytril™ Antibacterial Tablets Baytril™ Taste Tabs™ Antibacterial Tablets NADA 140-441, Supplemental approval, June 18, 1997; sponsor Elanco US Inc.; species: Dogs and cats; foi_id 481; FDA PDF
Indication
Management of diseases in dogs and cats associated with bacteria susceptible to enrofloxacin.
Dose regimen
5 to 20 mg/kg (2.27 to 9.07 mg/lb), oral (tablets), single daily dose or divided into two equal daily doses at 12 hour intervals, continued for at least 2 to 3 days beyond cessation of clinical signs, to a maximum of 30 days
The dose range of Baytril Antibacterial Tablets in dogs and cats is 5 to 20 mg/kg (2.27 to 9.07 mg/lb) of body weight, either as a single dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| other | 11 mg/kg dose required to maintain serum concentrations above MIC90 of Pseudomonas aeruginosa for the entire dosing interval | published literature (Walker et al., Am J Vet Res 1992), 11 mg/kg BID for 4 days, n = 6 adult dogs; flattened table row | Reference Conclusions/ -dosage of 11 mg/kg was required to maintain serum concentrations greater than the Explanation MIC90 of Pseudomonas aeruginosa for the entire dosing interval |
| other | Cmax/MIC ratio identified as most reliable predictor of fluoroquinolone success | published PK/PD literature cited in support of the dose range | Results of the following studies indicated that the most reliable predictor of successful therapy with flouroquinolones is the concentration-dependent value described by the ratio of the peak concentration of the drug divided by the drug's mean inhibitory concentration for that pathogen (Cmax/MIC). |
Target-animal safety
duration up to 30 days (dose range 5 to 20 mg/kg).
Safety of the dose range, for oral formulations, has been established in cats and dogs and is presented or referenced in the Freedom of Information Summaries for NADA 140-441.
| Finding | Quote |
|---|---|
| Enrofloxacin tablets have an adequate margin of safety in dogs and cats at 5-20 mg/kg for a maximum of 30 days | Conclusions: Enrofloxacin tablets have an adequate margin of safety in dogs and cats when administered over a dose range of 5 to 20 mg/kg for a maximum of 30 days. |
| In several referenced studies the oral doses exceeded the upper limit of the new dose range | In several studies, the oral doses administered exceeded the recommended upper limit of the dose range for the tablet formulation. |
Effectiveness
No new clinical study; effectiveness of the 5-20 mg/kg dose range supported by published clinical literature (Table 1) and PK/PD literature (Cmax/MIC, AUC/MIC); result: Agency accepted published literature as support for the broader dose range and 30-day maximum duration
D. Conclusion: The published scientific literature, concerning fluoroquinolone antimicrobial agents, supports a greater spectrum of activity in bacteriocidal activity for enrofloxacin with the dose range and duration as provided by this supplement.
Extraction notes: 1997 supplemental approval (joint FOI for NADA 140-441 tablets and NADA 140-913 injectable) revising the tablet dose to a 5-20 mg/kg range, indication to 'management of diseases associated with bacteria susceptible to enrofloxacin' and maximum duration to 30 days. No new sponsor studies: effectiveness is supported by published literature (Table 1) and PK/PD literature; safety by tabulated summaries (Tables 2 and 3) of NADA 140-441 studies. PK entries are literature-cited values from a flattened table (row labels 'Reference', 'Conclusions/', 'Explanation' interleave the text); no sponsor PK data. Table 2 dog safety trial rows were flattened by PDF extraction and are not quoted; dose_multiples left empty.
Baytril™ Antibacterial Injectable Solution NADA 140-913, Supplemental approval, June 18, 1997; sponsor Elanco US Inc.; species: Dogs; foi_id 527; FDA PDF
Indication
Management of diseases in dogs associated with bacteria susceptible to enrofloxacin (injectable solution supplement is for dogs).
Dose regimen
2.5 mg/kg (1.13 mg/lb), intramuscular injection, single injection, followed by oral tablet treatment in 12 hours, initial dose only; tablets continue the regimen
The dose of Baytril Injectable Solution for dogs is 2.5 mg/kg (1.13 mg/lb) as a single injection. The injectable dose should be followed by oral tablet treatment in 12 hours.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| other | 11 mg/kg dose required to maintain serum concentrations above MIC90 of Pseudomonas aeruginosa for the entire dosing interval | published literature (Walker et al., Am J Vet Res 1992), 11 mg/kg BID for 4 days, n = 6 adult dogs; flattened table row | Reference Conclusions/ -dosage of 11 mg/kg was required to maintain serum concentrations greater than the Explanation MIC90 of Pseudomonas aeruginosa for the entire dosing interval |
| other | Cmax/MIC ratio identified as most reliable predictor of fluoroquinolone success | published PK/PD literature cited in support of the dose range | Results of the following studies indicated that the most reliable predictor of successful therapy with flouroquinolones is the concentration-dependent value described by the ratio of the peak concentration of the drug divided by the drug's mean inhibitory concentration for that pathogen (Cmax/MIC). |
Target-animal safety
duration up to 30 days (dose range 5 to 20 mg/kg).
Safety of the dose range, for oral formulations, has been established in cats and dogs and is presented or referenced in the Freedom of Information Summaries for NADA 140-441.
| Finding | Quote |
|---|---|
| Enrofloxacin tablets have an adequate margin of safety in dogs and cats at 5-20 mg/kg for a maximum of 30 days | Conclusions: Enrofloxacin tablets have an adequate margin of safety in dogs and cats when administered over a dose range of 5 to 20 mg/kg for a maximum of 30 days. |
| In several referenced studies the oral doses exceeded the upper limit of the new dose range | In several studies, the oral doses administered exceeded the recommended upper limit of the dose range for the tablet formulation. |
Effectiveness
No new clinical study; effectiveness of the 5-20 mg/kg dose range supported by published clinical literature (Table 1) and PK/PD literature (Cmax/MIC, AUC/MIC); result: Agency accepted published literature as support for the broader dose range and 30-day maximum duration
D. Conclusion: The published scientific literature, concerning fluoroquinolone antimicrobial agents, supports a greater spectrum of activity in bacteriocidal activity for enrofloxacin with the dose range and duration as provided by this supplement.
Extraction notes: Same FOI document as foi 481 (joint supplement for NADA 140-441 and 140-913). For the injectable the supplement only revises the indication statement; the injectable dose (2.5 mg/kg IM single dose) is unchanged. 1997 supplemental approval (joint FOI for NADA 140-441 tablets and NADA 140-913 injectable) revising the tablet dose to a 5-20 mg/kg range, indication to 'management of diseases associated with bacteria susceptible to enrofloxacin' and maximum duration to 30 days. No new sponsor studies: effectiveness is supported by published literature (Table 1) and PK/PD literature; safety by tabulated summaries (Tables 2 and 3) of NADA 140-441 studies. PK entries are literature-cited values from a flattened table (row labels 'Reference', 'Conclusions/', 'Explanation' interleave the text); no sponsor PK data. Table 2 dog safety trial rows were flattened by PDF extraction and are not quoted; dose_multiples left empty.
Zobuxa™ NADA 200-517, Original approval, June 20, 2013; sponsor Elanco US Inc.; species: Cats and dogs; foi_id 1211; FDA PDF
Indication
Management of diseases associated with bacteria susceptible to enrofloxacin (dogs and cats).
Dose regimen
Dogs 5-20 mg/kg (2.27 to 9.07 mg/lb); cats 5 mg/kg (2.27 mg/lb), oral, single daily dose or divided into two equal daily doses at 12 hour intervals, continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days
Dogs: Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition. Cats: Administer orally at 5 mg/kg (2.27 mg/lb) of body weight.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | generic 14012 vs RLNAD 13592 (ng/mL)*hour (geometric means); CI 99.0%-107.4% | dogs, 136 mg tablet single oral dose, 16 fasted healthy male Beagles, two-way crossover (Table 2; columns: generic mean, RLNAD mean, lower bound, upper bound) | AUC (ng/mL)*hour 14012* 13592* 99.0% 107.4% |
| cmax | generic 4346 vs RLNAD 4296 ng/mL (geometric means); CI 94.4%-108.5% | dogs, 136 mg tablet, fasted, crossover (Table 2) | CMAX (ng/mL) 4346* 4296* 94.4% 108.5% |
| tmax | generic 1.10 vs RLNAD 1.38 hour (arithmetic means) | dogs, 136 mg tablet, fasted, crossover (Table 2) | TMAX (hour) 1.10† 1.38† N/A N/A |
| auc | generic 19961 vs RLNAD 18461 (ng/mL)*hour (geometric means); CI 99.9%-117.1% | CATS, 22.7 mg tablet single oral dose, fasted male European Short Haired cats (15 in crossover), Table 1 | AUC (ng/mL)*hour 19961* 18461* 99.9% 117.1% |
| cmax | generic 2021 vs RLNAD 1914 ng/mL (geometric means); CI 98.9%-112.7% | CATS, 22.7 mg tablet, fasted, crossover (Table 1) | CMAX (ng/mL) 2021* 1914* 98.9% 112.7% |
| tmax | generic 1.40 vs RLNAD 1.37 hour (arithmetic means) | CATS, 22.7 mg tablet, fasted, crossover (Table 1) | TMAX (hour) 1.40† 1.37† N/A N/A |
Effectiveness
Bioequivalence (not a clinical effectiveness study): randomized, two-way crossover, single-dose blood-level study of generic 136 mg enrofloxacin tablet vs BAYTRIL TASTE TABS 136 mg in fasted healthy male Beagle dogs, 7-day washout; n = 16; primary endpoint: 90% confidence interval of generic/RLNAD ratio for AUC and CMAX within 80.00%-125.00%; result: Both AUC and CMAX within the prescribed bounds; bioequivalence demonstrated (a parallel study in 15 cats with the 22.7 mg tablet also met the criteria)
The study was conducted as a two-period, two-treatment crossover design using 16 dogs with a 7 day washout between periods.
Extraction notes: Generic ANADA (Novartis) referencing BAYTRIL TASTE TABS NADA 140-441. New target animal safety and effectiveness data were not required; the effectiveness field holds the dog blood-level bioequivalence study. PK rows are Table 1 (cats) and Table 2 (dogs) rows quoted as extracted; asterisk marks geometric means and dagger arithmetic means; CI values are 90% confidence bounds. Biowaiver (dissolution) granted for the 22.7, 68 and 272 mg dog strengths and 68/136 mg cat strengths; 272 mg strength added via suitability petition.
Enroflox® Chewable Tablets NADA 200-720, Original approval, March 11, 2022; sponsor Norbrook Laboratories, Ltd.; species: Dogs and cats; foi_id 12147; FDA PDF
Indication
Management of diseases associated with bacteria susceptible to enrofloxacin, in dogs and cats
Dose regimen
5-20 mg/kg (dogs), Oral, Once daily (or divided into two equal doses at 12-hour intervals), Selection of a dose within the range based on clinical experience, severity of disease and pathogen susceptibility; may be given as a single daily dose or divided into two equal doses at 12-hour intervals; continue at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days. Cats: 5 mg/kg once daily.
Dogs: Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 2.1880 (ppm)*hour (geometric mean, generic) | Dog BE study (Study 025/17): 136 mg generic tablet, single oral dose, fasted beagles, n=24 crossover. Row columns: parameter, generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI | AUC (ppm)*hour 2.1880† 2.1351† 1.7 0.93 1.20 |
| auc | 2.1351 (ppm)*hour (geometric mean, RLNAD Baytril Taste Tabs) | Dog BE study: 136 mg RLNAD tablet, single oral dose, fasted beagles, n=24 | AUC (ppm)*hour 2.1880† 2.1351† 1.7 0.93 1.20 |
| cmax | 0.9558 ppm (geometric mean, generic) | Dog BE study: 136 mg generic tablet, single oral dose, fasted, n=24 | CMAX (ppm) 0.9558† 0.8688† 1.5 0.98 1.21 |
| cmax | 0.8688 ppm (geometric mean, RLNAD) | Dog BE study: 136 mg RLNAD tablet, single oral dose, fasted, n=24 | CMAX (ppm) 0.9558† 0.8688† 1.5 0.98 1.21 |
| tmax | 1.69 hours (arithmetic mean; SD 0.55), generic | Dog BE study: 136 mg generic tablet, single oral dose, fasted, n=24 | TMAX (hours) (SD)‡ 1.69 (0.55)‡ 1.75 (0.72)‡ NE NE NE |
| tmax | 1.75 hours (arithmetic mean; SD 0.72), RLNAD | Dog BE study: 136 mg RLNAD tablet, single oral dose, fasted, n=24 | TMAX (hours) (SD)‡ 1.69 (0.55)‡ 1.75 (0.72)‡ NE NE NE |
| auc | 18.20 (ppm)*hour (geometric mean, generic) — CATS | Cat BE study (Study 024/17): 22.7 mg generic tablet, single oral dose, fasted domestic shorthair cats, n=20 crossover (RLNAD 18.75) | AUC (ppm)*hour 18.20† 18.75† 0.98 0.90 1.06 |
| cmax | 2.16 ppm (geometric mean, generic) — CATS | Cat BE study: 22.7 mg generic tablet, single oral dose, fasted cats, n=20 (RLNAD 2.15) | CMAX (ppm) 2.16† 2.15† 1.01 0.92 1.13 |
Effectiveness
Blood-level bioequivalence study (ANADA; not a clinical effectiveness trial): randomized, masked, two-period, two-sequence, two-treatment, single-dose crossover in fasted beagle dogs, 136 mg generic Enroflox Chewable Tablet vs 136 mg Baytril Taste Tabs (RLNAD), 21-day washout (Study No. 025/17); n = 24; primary endpoint: CMAX and AUC (time 0 to last quantifiable concentration); bioequivalence if the 90% confidence interval of the geometric mean ratio (generic:RLNAD) for both lies within 0.80-1.25; result: Bioequivalence demonstrated in dogs: AUC ratio 90% CI 0.93-1.20 and CMAX ratio 90% CI 0.98-1.21 (Table II.1). The 22.7 mg and 68 mg strengths were granted a biowaiver in dogs on comparative dissolution data.
The laboratory study was conducted as a randomized, masked two-period, two- sequence, two-treatment, single-dose crossover design using 24 beagle dogs with a 21-day washout between periods.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Serious adverse events (dog BE study) | There were no serious adverse events reported during the study. |
Extraction notes: Generic ANADA: effectiveness and target animal safety data were not required; no TAS study in the summary. The effectiveness field holds the pivotal in vivo blood-level bioequivalence study in dogs (labelled as such, not a clinical trial). A parallel BE study in 20 fasted cats (22.7 mg tablets, 35-day washout) is also in the summary; two cat PK rows are included and labelled CATS. The 'Ratio' column of the dog Table II.1 reads '1.7' and '1.5' exactly as printed in the summary although the 90% CIs (0.93-1.20; 0.98-1.21) imply ratios near 1.0-1.1; quoted as extracted, not corrected. Dose regimen recorded for dogs; the summary also gives cats 5 mg/kg once daily.
Enrofloxacin Flavored Tablets NADA 200-810, Original approval, March 24, 2025; sponsor Hikma Pharmaceuticals USA, Inc.; species: Dogs and cats; foi_id 16706; FDA PDF
Indication
Management of diseases associated with bacteria susceptible to enrofloxacin, in dogs and cats
Dose regimen
5 - 20 mg/kg (dogs), Oral, Once daily (or divided into two equal doses at 12-hour intervals), Selection of a dose within the range based on clinical experience, severity of disease and pathogen susceptibility; may be given as a single daily dose or divided into two equal doses at 12-hour intervals; continue at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days. Cats: 5 mg/kg once daily.
Dogs: Administer orally at a rate to provide 5 - 20 mg/kg (2.27 to 9.07 mg/lb) of body weight.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 22031.0 (ng/mL)*hour (geometric mean, generic) | Dog BE study (AKR501-003): 136 mg generic tablet, single oral dose, fasted intact male beagles, n=30 crossover. Row columns: parameter, generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI | AUC (ng/mL)*hour 22031.0† 21235.7† 1.04 0.99 1.08 |
| auc | 21235.7 (ng/mL)*hour (geometric mean, RLNAD Baytril Taste Tabs) | Dog BE study: 136 mg RLNAD tablet, single oral dose, fasted, n=30 | AUC (ng/mL)*hour 22031.0† 21235.7† 1.04 0.99 1.08 |
| cmax | 3380.6 ng/mL (geometric mean, generic) | Dog BE study: 136 mg generic tablet, single oral dose, fasted, n=30 | CMAX (ng/mL) 3380.6† 3311.2† 1.02 0.97 1.07 |
| cmax | 3311.2 ng/mL (geometric mean, RLNAD) | Dog BE study: 136 mg RLNAD tablet, single oral dose, fasted, n=30 | CMAX (ng/mL) 3380.6† 3311.2† 1.02 0.97 1.07 |
| tmax | 1.81 hours (arithmetic mean; SD 0.75), generic | Dog BE study: 136 mg generic tablet, single oral dose, fasted, n=30 | TMAX (hours) (SD)‡ 1.81 (0.75)‡ 1.51 (0.62)‡ NE NE NE |
| tmax | 1.51 hours (arithmetic mean; SD 0.62), RLNAD | Dog BE study: 136 mg RLNAD tablet, single oral dose, fasted, n=30 | TMAX (hours) (SD)‡ 1.81 (0.75)‡ 1.51 (0.62)‡ NE NE NE |
| auc | 13563.0 (ng/mL)*hour (geometric mean, generic) — CATS | Cat BE study (AKR501-002): 22.7 mg generic tablet, single oral dose, fasted male domestic shorthair cats, n=30 crossover (RLNAD 12780.4) | AUC (ng/mL)*hour 13563.0† 12780.4† 1.06 1.03 1.09 |
| cmax | 1355.1 ng/mL (geometric mean, generic) — CATS | Cat BE study: 22.7 mg generic tablet, single oral dose, fasted cats, n=30 (RLNAD 1290.9) | CMAX (ng/mL) 1355.1† 1290.9† 1.05 0.98 1.12 |
Effectiveness
Blood-level bioequivalence study (ANADA; not a clinical effectiveness trial): randomized, masked, two-period, two-sequence, two-treatment, single-dose crossover in fasted intact male Beagle dogs (414-1075 days old, 9.1-12.0 kg), 136 mg generic tablet vs 136 mg Baytril Taste Tabs, 7-day washout (Study No. AKR501-003); n = 30; primary endpoint: CMAX and AUC (time 0 to last quantifiable concentration); bioequivalence if the 90% confidence interval of the geometric mean ratio (generic:RLNAD) for both lies within 0.80-1.25; result: Bioequivalence demonstrated in dogs: AUC ratio 1.04 (90% CI 0.99-1.08), CMAX ratio 1.02 (90% CI 0.97-1.07) (Table II.1). 22.7 mg and 68 mg strengths granted a biowaiver in dogs (rapid dissolution, >85% in 15 minutes).
The laboratory study was conducted as a randomized, masked two-period, two- sequence, two-treatment, single-dose crossover design using 30 dogs with a 7-day washout between periods.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Serious adverse events (dog BE study) | There were no serious adverse events reported during the study. |
Extraction notes: Generic ANADA: effectiveness and target animal safety data were not required; no TAS study in the summary. The effectiveness field holds the pivotal in vivo blood-level bioequivalence study in dogs (labelled as such, not a clinical trial). A parallel BE study in 30 fasted cats (22.7 mg tablets, 14-day washout) is also in the summary; two cat PK rows are included and labelled CATS. Dose regimen recorded for dogs; cats 5 mg/kg once daily.
Baytril™ Antibacterial Injectable Solution NADA 140-913, Original approval, May 04, 1990; sponsor Elanco US Inc.; species: Dogs; foi_id 3579; FDA PDF
Indication
Treatment of dermal infections (wounds and abscesses), respiratory infections (pneumonia, tonsillitis, rhinitis) and urinary cystitis in dogs caused by susceptible strains of E. coli, Klebsiella pneumoniae, Proteus mirabilis and Staphylococcus aureus.
Dose regimen
2.5 mg/kg (1.13 mg/lb), intramuscular (IM) injection as the initial dose, then oral tablets, single IM dose followed by tablets every 12 hours, tablets continued twice daily for two to three days beyond cessation of clinical signs to a maximum of ten days
The optimum dose of Baytril (brand of enrofloxacin) has been established at 2.5 mg/kg (1.13 mg/lb) of body weight administered twice daily (every 12 hours). Baytril Tablets should be given twice daily for two to three days beyond the cessation of clinical signs to a maximum of ten days. Baytril Injectable Solution may be used as the initial dose. It should be administered intramuscularly (IM) as a single dose, followed by Baytril Tablets every 12 hours.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| other | serum enrofloxacin after IM injectable: 0.72, 1.09, 1.00, 0.94, 0.82, 0.54, 0.20, 0.10 (units not stated in extracted table) | Table 1 bioequivalency crossover study, 24 dogs, 2.27% injectable IM at 2.5 mg/kg; columns are pretreatment then 0.25, 0.50, 0.75, 1.00, 2.0, 4.0, 8.0 and 12.0 hours after treatment | Injectable 24 0.00 0.72 1.09 1.00 0.94 0.82 0.54 0.20 0.10 |
| other | serum enrofloxacin after oral tablet: 0.08, 0.47, 0.70, 0.70, 0.70, 0.55, 0.18, 0.09 (units not stated in extracted table) | Table 1, same 24 dogs, tablet 2.5 mg/kg oral; columns as above | Tablet 24 0.00 0.08 0.47 0.70 0.70 0.70 0.55 0.18 0.09 |
| other | injectable serum levels higher than tablet only in the first hour (P<0.01); no other significant differences | crossover comparison of AUC, Cmax, Tmax with 90% confidence intervals | Other than the first hour when the injectable values were higher (P<0.01), there were no significant differences between the tablet and injectable group. |
| bioavailability | injectable at least as bioavailable as the tablet | 2.5 mg/kg single dose, IM vs oral, 24 dogs crossover | Based upon this approach, the injectable formulation is at least as bioavailable as the tablet formulation. |
Target-animal safety
dose multiples 1X, 3X, 5X; duration 30 days total (3 IM injections then oral tablets twice daily; 3x the labeled duration); animals 16 adult Beagle dogs in groups of 4 (4 nontreated controls).
M. Kohlenberg of Shawnee Mission, Kansas conducted a study in 16 adult, male and female Beagle dogs in groups of 4 with a combination of the 2.27% injectable formulation intended for market and the approved 22.7 mg tablet currently being marketed. The purpose of this study was to evaluate for clinical signs and histopathology following dosing at 1, 3, and 5x doses for a 3x duration.
| Finding | Quote |
|---|---|
| No adverse effects in any parameter at 1X, 3X or 5X for 3X duration; adequate safety margin | No adverse effects occurred in any of the parameters and the study concluded an adequate safety margin based upon treatment at 5 times the use rate for 3 times the labeled duration. |
| Drug tolerance at 25x (62.5 mg/kg IM): excitation, incoordination, recumbency, convulsions, tremors, salivation, vomition, depression in 2 dogs, normal within 24 hours | Signs of toxicosis in the 2 treated dogs included excitation, incoordination, recumbency, convulsions, muscle tremors, salivation, vomition, alterations in respiratory rate, and slight to severe depression, but both were clinically normal within 24 hours post-treatment. |
| Local tolerance: single IM injection of 2.27% formulation caused no tissue swelling or clinically significant lesions | No tissue swelling occurred and no clinically significant lesions were present at necropsy. Histology readings indicated adequate healing. |
Effectiveness
Pivotal well-controlled, blinded multi-site clinical field trial (March-May 1988); dogs with naturally occurring dermal, otic, respiratory, enteric or urinary infections randomized to enrofloxacin 2.27% injectable (single IM injection at 1 mL/9.1 kg) followed by tablets 2.5 mg/kg BID for up to ten days, versus Tribrissen injection followed by tablets (positive control); n = 115 evaluated clinically (61 enrofloxacin, 54 positive control) of 128 enrolled; primary endpoint: percentage reduction in clinical score (0-4) by body system, pathogen elimination on post-treatment culture, and subjective evaluations; result: Enrofloxacin had a medically significant effect on lesions comparable to Tribrissen (e.g. dermal 84.8% vs 80.6% score reduction); 74 of 99 isolates (74.7%) eliminated vs 46 of 71 (64.8%) for Tribrissen; no drug-related side effects
Of the 128 dogs initially selected, 13 were omitted from any assessment because of protocol deviations that could be expected to influence the results. Clinical evaluations subsequently were conducted on 115 dogs, 61 dosed with enrofloxacin and 54 with the positive control.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| drug related side effects (pivotal clinical trial) | No drug related side effects were reported following dosing with either enrofloxacin or Tribrissen. | ||
| moderate tissue swelling at injection site (laboratory/clinical safety evaluation, 88 enrofloxacin dogs) | 2.3% | With the injections, there was a 2.3% incidence of moderate tissue swelling following enrofloxacin treatment and a 32.1% incidence of slight to moderate pain following the Tribrissen injections. | |
| emesis (laboratory/clinical safety evaluation) | 2 cases | 2 cases | Two cases of emesis were observed following treatment with each of the 2 products. |
| side effects in field trials (122 enrofloxacin-treated dogs) | No side effects were reported in the enrofloxacin treated dogs. |
Extraction notes: Original NADA 140-913 (injectable) summary, 1990. Section headings were parsed into general_information. PK: Table 1 of the tablet-vs-injectable bioequivalency crossover study is quoted as extracted; the table title was garbled by PDF extraction ('Summary of Daily Gain/Chick') and concentration units are not stated in the extracted text (values appear to be serum enrofloxacin, presumably mcg/mL). Table 2 case distribution header repeats 'Enrofloxacin' for the Tribrissen columns (extraction artifact). Control-group figure for tissue swelling not reported (32.1% refers to pain after Tribrissen injections, a different term).
Enroflox™ Injection for Dogs 2.27% NADA 200-513, Original approval, May 08, 2014; sponsor Norbrook Laboratories, Ltd.; species: Dogs; foi_id 1209; FDA PDF
Indication
Management of diseases in dogs associated with bacteria susceptible to enrofloxacin.
Dose regimen
2.5 mg/kg (1.13 mg/lb), i.e. 1 mL/9.1 kg (20 lb), intramuscular (IM), single injection, followed by oral tablet treatment in 12 hours
Administer intramuscularly (IM) as a single injection at the rate of 1 mL/9.1 kg (20 lb) to provide 2.5 mg/kg (1.13 mg/lb). The injectable dose should be followed by oral tablet treatment in 12 hours.
Extraction notes: Generic ANADA (Norbrook) referencing BAYTRIL Injectable Solution NADA 140-913. Biowaiver granted based on formulation characteristics (same active ingredient, concentration and dosage form; no inactive ingredients affecting bioavailability); CVM did not require effectiveness or target animal safety studies. No study data in the summary.
Enrofloxacin Flavored Tablets NADA 200-680, Original approval, May 21, 2020; sponsor Felix Pharmaceuticals Pvt. Ltd.; species: Dogs and cats; foi_id 9048; FDA PDF
Indication
Management of diseases associated with bacteria susceptible to enrofloxacin in dogs and cats.
Dose regimen
Dogs 5-20 mg/kg (2.27 to 9.07 mg/lb), oral, single daily dose or divided into two equal daily doses at 12 hour intervals, continued for at least 2-3 days beyond cessation of clinical signs to a maximum of 30 days; cats 5 mg/kg (2.27 mg/lb)
Dogs: Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | test 14368 vs reference 14292 (ng/mL)*hour (geometric means); ratio 1.01; CI 87%-116% | dogs, 136 mg tablet single oral dose, 24 healthy fasted beagle dogs, two-period two-sequence crossover, 7-day washout (Table II.1; columns: test mean, reference mean, ratio, lower bound %, upper bound %) | AUC (ng/mL)*hour 14368† 14292† 1.01 87 116 |
| cmax | test 2670 vs reference 2553 ng/mL (geometric means); ratio 1.05; CI 93%-117% | dogs, 136 mg tablet, fasted, crossover (Table II.1) | Cmax (ng/mL) 2670† 2553† 1.05 93 117 |
| tmax | test 1.5 vs reference 1.8 hour (arithmetic means) | dogs, 136 mg tablet, fasted, crossover (Table II.1) | Tmax (hour) 1.5‡ 1.8‡ NE NE NE |
| auc | test 13967 vs reference 13752 (ng/mL)*hour (geometric means); ratio 1.02; CI 98%-105% | CATS, 22.7 mg tablet single oral dose, 24 healthy fasted purpose-bred male and female cats, crossover, 14-day washout (Table II.2) | AUC (ng/mL)*hour 13967† 13752† 1.02 98 105 |
| cmax | test 1549 vs reference 1517 ng/mL (geometric means); ratio 1.02; CI 96%-109% | CATS, 22.7 mg tablet, fasted, crossover (Table II.2) | Cmax (ng/mL) 1549† 1517† 1.02 96 109 |
| tmax | test 1.25 vs reference 1.15 hour (arithmetic means) | CATS, 22.7 mg tablet, fasted, crossover (Table II.2) | Tmax (hour) 1.25‡ 1.15‡ NE NE NE |
Effectiveness
Bioequivalence (not a clinical effectiveness study): randomized, two-period, two-sequence, single-dose crossover blood-level study of generic 136 mg enrofloxacin tablet vs Baytril 136 mg tablet in healthy fasted beagle dogs, 7-day washout; n = 24; primary endpoint: 90% confidence interval of test/reference ratio for AUC and CMAX within 80.00%-125.00%; result: Both AUC and CMAX within the prescribed bounds; bioequivalence demonstrated; no significant adverse events (a parallel study in 24 cats with the 22.7 mg tablet also met the criteria)
A randomized, two-period, two-sequence, single-dose crossover study to evaluate the relative bioavailability of the generic 136 mg enrofloxacin tablet in 24 healthy, fasted dogs.
Extraction notes: Generic ANADA (Felix Pharmaceuticals, corrected FOI summary 2020) referencing Baytril Taste Tabs NADA 140-441. New target animal safety and effectiveness data were not required; effectiveness field holds the dog blood-level bioequivalence study. PK rows quoted as extracted from Tables II.1 (dogs) and II.2 (cats); dagger marks geometric means, double dagger arithmetic means, NE = not estimated; CI values are 90% confidence bounds. Dissolution biowaiver granted for 22.7/68 mg (dogs) and 68/136 mg (cats).
Baytril™ Antibacterial Tablets Baytril™ Taste Tabs™ Antibacterial Tablets NADA 140-441, Supplemental approval, May 31, 1990; sponsor Elanco US Inc.; species: Cats; foi_id 480; FDA PDF
Indication
Supplement adds cats: treatment of dermal infections (wounds and abscesses) caused by susceptible strains of Pasteurella multocida, Staphylococcus aureus and Staphylococcus epidermidis.
Dose regimen
2.5 mg/kg (1.13 mg/lb), oral (tablet), twice daily (every 12 hours), 2-3 days beyond cessation of clinical signs to a maximum of 10 days; re-evaluate if no improvement within 5 days
The optimum dose of Baytril® (brand of enrofloxacin} Tablets in dogs and cats has been established at 2.5 mg/kg (1.13 mg/lb} of body weight administered twice daily (every 12 hours}. Baytril Tablets should be given twice daily for 2-3 days beyond the cessation of clinical signs to a maximum of 10 days.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| cmax | 1.21 mcg/mL (cats); 1.10 mcg/mL (dogs) | single oral 2.5 mg/kg tablet; 22 cats vs 24 dogs; columns Dogs, Cats; not different (P>0.05) | Peak (mcg/mL) 1.10 1.21 |
| tmax | 1.64 hrs (cats); 1.16 hrs (dogs) | single oral 2.5 mg/kg tablet; columns Dogs, Cats; not different (P>0.05) | Time to Peak (hrs) 1.16 1.64 |
| auc | 8.1 (cats); 4.4 (dogs) | single oral 2.5 mg/kg tablet, 24 h sampling; columns Dogs, Cats; AUC larger in cats (P<0.05), units not stated in table | AUC+ 4.4 8.1 |
| other | AUC larger in cats than dogs, attributed to different metabolism | dog vs cat bioequivalence trial | The cats maintained the serum levels longer producing an area-under-the-curve (AUC) that was larger than for dogs (P<O.OS). |
| other | serum 0.48 / 0.58 / 0.18 mcg/mL | tissue distribution study, 12 cats, single oral 2.5 mg/kg, 2 males + 2 females per time point; columns are 2 h, 6 h, 12 h post-dose | Serum 0.48 0.58 0.18 |
| other | urine 12.81 / 31.63 / 26.41 mcg/mL | tissue distribution study, single oral 2.5 mg/kg; columns are 2 h, 6 h, 12 h post-dose | Urine 12.81 31.63 26.41 |
| other | skin 0.46 / 2.38 / 0.17 mcg/g | tissue distribution study, single oral 2.5 mg/kg; columns are 2 h, 6 h, 12 h post-dose | Skin 0.46 2.38 0.17 |
| other | bile 2.13 / 9.67 / 1.97 mcg/mL | tissue distribution study, single oral 2.5 mg/kg; columns are 2 h, 6 h, 12 h post-dose | Bile 2.13 9.67 1.97 |
Target-animal safety
dose multiples 1X (5 mg/kg/day), 3X (15 mg/kg/day), 5X (25 mg/kg/day), 10X (50 mg/kg/day, tolerance test), 25X (125 mg/kg/day, tolerance test); duration 30 consecutive days (3X labeled duration); tolerance test up to 6 days; animals 3 groups (4 animals each) plus 4 nontreated controls.
The enrofloxacin 5.7 mg tablets were administered orally twice daily to the 3 groups (4 animals each) at 2.5, 7.5 and 12.5 mg/kg or at a total daily dose of 5, 15 and 25 mg/kg (2.27, 6.8 and 11.34 mg/lb) for 30 consecutive days.
| Finding | Quote |
|---|---|
| 7-10 month cats: no clinically significant changes at up to 25 mg/kg/day for 30 days | There were no clinically significant changes or biologically significant trends with regard to any of the monitored parameters, i.e., clinical signs, body weights, clinical chemistries/hematology and gross necropsy. |
| Occasional vomiting in treated and control young cats | Occasional vomition was experienced by 2 of 4 animals receiving 5 mg/kg (IX), 3 of 4 receiving 15 mg/kg (3X), 2 of 4 receiving 25 mg/kg (SX)and 1 of 4 nontreated controls. |
| Tolerance test: 50 and 125 mg/kg/day produced salivation, vomiting, inappetence, depression, tremors, incoordination and convulsions | Clinical signs of toxicosis induced in the 4 treated cats were salivation, change in behavior, vomition, inappetance, depression, muscle tremors, incoordination and convulsions. |
| Both cats at 125 mg/kg/day (25X) died on days 4 and 5 | The 2 cats receiving the daily treatments of 125 mg/kg expired on days 4 and 5. |
| 5-7 month kittens: articular cartilage lesions in the 2 males given 25 mg/kg/day for 30 days | Findings at necropsy indicated no significant lesions of the soft tissues, however, the 2 male cats that received 25 mg/kg daily treatments had lesions of the articular cartilage. |
| 3-4 month kittens: no articular cartilage lesions at up to 25 mg/kg/day for 30 days | No lesions of the articular cartilage were observed at necropsy or histologically in this study as were observed in Study No. 4. |
Effectiveness
Well-controlled, blinded multi-site (22 practitioners) clinical trial in cats with naturally occurring bacterial infections, enrofloxacin tablets 2.5 mg/kg BID for up to 10 days vs Hetacin K (hetacillin) 50 mg BID positive control; efficacy by clinical score reduction, pathogen elimination and subjective ratings; n = 223 cats (111 enrofloxacin; 112 Hetacin K); primary endpoint: Percent reduction in clinical score by body system and pathogen elimination on post-treatment culture; result: Dermal clinical score reduction 91.5% (65 cases) enrofloxacin vs 88.5% (72) Hetacin K; dermal pathogen elimination 98.6% (71 isolates) vs 93.8% (81); overall pathogen elimination 91.3% vs 88.7%; efficacy rated excellent/good in 93.7% vs 91.1%; no drug-related side effects
Clinical evaluations were subsequently conducted on 223 cats, 111 dosed with enrofloxacin and 112 with the positive control {Table 2}.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Drug-related side effects (field trial) | No drug-related side effects were observed during this study with either antibacterial. | ||
| Safety rated excellent by practitioners (field safety confirmation, 124 cats) | 118 (95.1%) | Veterinary practitioners rated safety for enrofloxacin treatment as excellent for 118 (95.1%) of the cases, 4 (3.2%) as good and 2 were not recorded. |
Extraction notes: 1990 supplemental approval adding cats to a dog NADA; the summary is a feline summary (dog data are cross-referenced to the 1989 original). PK values are from the dog-vs-cat serum bioequivalence study (Table 1, columns Dogs then Cats; 24 dogs, 22 cats) and the feline tissue distribution study (Table 7, columns 2, 6 and 12 hours; tissue levels mcg/g, fluid levels mcg/mL). The TAS design quote is the 30-day study in 7-10 month old cats; additional 30-day studies in 3-4 month and 5-7 month kittens, a 15-day liquid-formulation study in 8-10 week kittens, and a 6-day 50/125 mg/kg tolerance test are captured as findings. OCR artifacts ('}' for ')', 'IX', 'SX', 'P<O.OS') are reproduced verbatim in quotes.
Reproduce: foi_structured_search(query="Enrofloxacin") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).