Orbifloxacin: what the FDA reviewed for dog products
4 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Orbifloxacin, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Canine and feline; Cats and Dogs; Dogs; Dogs and cats.
Products
- Orbax® (NADA/ANADA 141-305)
- Orbax® Tablets (NADA/ANADA 141-081)
Orbax® Tablets NADA 141-081, Original approval, April 22, 1997; sponsor Intervet, Inc.; species: Dogs; foi_id 2580; FDA PDF
Indication
Management of diseases in dogs associated with bacteria susceptible to orbifloxacin; clinical efficacy established in skin and soft tissue infections (wounds and abscesses) and urinary tract infections (cystitis).
Dose regimen
2.5 mg/kg to 7.5 mg/kg, oral (tablet), once daily, up to a maximum of 30 days; skin/soft tissue infections 2-3 days beyond cessation of clinical signs; cystitis at least 10 consecutive days with re-evaluation if no improvement within 5 days
The ORBAX (brand of orbifloxacin) Tablets dose is 2.5 mg/kg to 7.5 mg/kg of body weight administered orally once daily for up to a maximum of 30 days of therapy, if necessary.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| clearance | 2.92 ± 0.18 mL/min/kg | IV bolus 2.5 mg/kg, 12 Beagle dogs (6M/6F), crossover | Total body clearance, mL/min/kg 2.92 ± 0.18 |
| other | 1.2 ± 0.2 L/kg | volume of distribution at steady state (Vss), IV 2.5 mg/kg, n=12 | Volume of distribution at steady state, Vss (L/kg) 1.2 ± 0.2 |
| clearance | 3.02 ± 0.20 mL/min/kg | total body clearance/F, single oral tablet 2.5 mg/kg, n=12 | Total body clearance/F, mL/min/kg 3.02 ± 0.20 |
| cmax | 2.33 ± 0.28 ug/mL | single oral tablet 2.5 mg/kg, n=12 | Maximum concentration, Cmax (ug/mL) 2.33 ± 0.28 |
| tmax | 46 ± 27 minutes | single oral tablet 2.5 mg/kg, n=12 | Time of maximum concentration, Tmax (minutes) 46 ± 27 |
| auc | 14.26 ± 1.4 ugh/mL | AUC0-infinity, single oral tablet 2.5 mg/kg, n=12 (unit printed as 'ugh/mL', i.e. ug·h/mL) | AUC0-infinity (ugh/mL) 14.26 ± 1.4 |
| half-life | 5.6 ± 1.1 hrs | terminal plasma half-life, single oral tablet 2.5 mg/kg, n=12 | Terminal plasma half-life, t1/2 (hrs) 5.6 ± 1.1 |
| bioavailability | approximately 97% | absolute bioavailability of a 2.5 mg/kg oral dose | The absolute bioavailability, F, of a 2.5 mg/kg oral dose is approximately 97%. |
Target-animal safety
dose multiples 1X, 3X, 5X; duration 30 consecutive days (7.5, 22.5, 37.5 mg/kg/day); plus a 30-day juvenile arthropathy study at 12.5 and 25 mg/kg/day in 8-10 week old puppies; animals 32.
Animals: Thirty-two (32) young adult (approximately 15-16 month old) beagle dogs (16 males and 16 females) weighing 9.43 - 14.31 kg of body weight at study initiation were randomly allotted into four (4) groups consisting of four (4) males and four (4) females in each of the control, 1X, 3X, and 5X dose groups.
| Finding | Quote |
|---|---|
| No drug-related adverse reactions other than fecal discoloration (tablet coating) at 3X and 5X. | Other than discoloration of feces in the 3X and 5X dose groups due to the tablet coating, there were no apparent drug-related adverse reactions reported. |
| Absorption increased proportionately with dose (linear PK) up to 37.5 mg/kg daily for 30 days; no accumulation. | it is apparent that the absorption of orally administered orbifloxacin increases proportionately with dose (exhibits linear pharmacokinetics) up to 37.5 mg/kg when given daily for 30 days. |
| Conclusion: 7.5 mg/kg/day for up to 30 days produces no systemic effects in young adult Beagles. | Results of this study support the conclusion that oral administration of orbifloxacin at the maximum intended clinical dose of 7.5 mg/kg/day for a maximum duration of thirty (30) days produces no systemic effects in young adult (15-16 month) beagle dogs. |
| Juvenile study: fluoroquinolone-type arthralgia (limping, carpal flexion) in 6/8 puppies at 12.5 mg/kg and 6/8 at 25 mg/kg. | Clinical signs consistent with fluoroquinolone-induced arthralgia (e.g., limping and carpal flexion) were noted in six of eight dogs in the 12.5 mg/kg of body weight group and in six of eight in the 25mg/kg of body weight group. |
| Juvenile study: gross cartilage lesions in 5/8 high-dose puppies; microscopic arthropathy in all high-dose and 1 low-dose puppy; not safe in young growing dogs. | Under the conditions of the study, ORBAX (brand of orbifloxacin) Tablets, are not safe to use in young growing beagle dogs. |
Effectiveness
Multi-center, blinded, positive-controlled (enrofloxacin 2.5 mg/kg BID) clinical field study of dermal infections (wounds and abscesses) in dogs, 13 investigators in 10 states; orbifloxacin 2.5 mg/kg orally once daily for 5 or 10 days (Study 1330C-61-V93-152); n = 172 enrolled, 98 evaluated for clinical efficacy; primary endpoint: Wound healing at Day 5 and Day 11; bacterial elimination at Day 11; result: Orbifloxacin: 24 (43%) of 56 healed by Day 5 and 49 (88%) of 56 healed by Day 11 (enrofloxacin 16 (38%) of 42 and 38 of 42); overall Day 11 bacterial elimination 96% (115/120) for orbifloxacin vs 98% (94/96) for enrofloxacin. Companion UTI field study: 100% (31/31) bacterial elimination and 83% (20/24) excellent clinical response with 2.5 mg/kg once daily for 10 days
Animals: Forty-four (44) breeds, as well as mixed breeds were represented in the 172 cases enrolled. Ninety-two (92) dogs were male and eighty (80) were female. Ages ranged from nine (9) months to sixteen (16) years and weights ranged from 5.6 to 122 lbs. Ninety-eight (98) of the enrolled dogs were evaluated for clinical efficacy
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| No apparent drug-related adverse reactions (dose titration, UTI field study, soft tissue field study and PK study each state this) | No apparent drug-related adverse reactions were reported. |
Extraction notes: Original approval (1997). No Species/Class field in General Information; 'Dogs' taken from the indication. IV Table 1 lists the same value (14.32 ± 0.93) for both AUC0-infinity and terminal half-life, an apparent extraction/typesetting error, so neither IV value is extracted. The Day 11 healing table prints the enrofloxacin healed figure as '38 (38%)' of 42, an evident typo. Effectiveness also supported by a dose-titration infected surgical wound model (54 dogs; 2.5 mg/kg effective vs E. coli) and the UTI field study (96 enrolled, 49 evaluated for efficacy).
Orbax® Tablets NADA 141-081, Supplemental approval, March 03, 2006; sponsor Intervet, Inc.; species: Canine and feline; foi_id 615; FDA PDF
Indication
Management of diseases in dogs and cats associated with bacteria susceptible to orbifloxacin.
Dose regimen
2.5 to 7.5 mg/kg, oral (tablet), once daily, skin/soft tissue infections: 2-3 days beyond cessation of clinical signs to a maximum of 30 days; urinary tract infections: at least 10 consecutive days
Recommended Dosage: 2.5 to 7.5 mg/kg of bodyweight administered once daily. For the treatment of skin and associated soft tissue infections, ORBAX Tablets should be given for two (2) to three (3) days beyond the cessation of clinical signs to a maximum of 30 days. For the treatment of urinary tract infections, ORBAX Tablets should be administered for at least ten (10) consecutive days.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Post-approval voluntary reports (rare): hypersensitivity (facial edema, anaphylaxis/anaphylactoid reactions), neurologic (seizures, ataxia), behavioral (depression, lethargy), gastrointestinal (vomiting, anorexia); no counts given | Hypersensitivity: facial edema, anphylaxis/anaphylactoid reactions Neurologic: seizures, ataxia Behavioral: depression, lethargy Gastrointestinal: vomiting, anorexia |
Extraction notes: Category II labeling supplement (2006): adds post-approval adverse drug experience information and fluoroquinolone class statements on retinal toxicity in cats ('Do not exceed 7.5 mg/kg body weight per day in cats'). No new effectiveness, PK or target animal safety data; summary states 'New information was not required for this supplement'. Species/Class stated as 'Canine and feline'.
Orbax® NADA 141-305, Original approval, March 25, 2010; sponsor Intervet, Inc.; species: Cats and Dogs; foi_id 868; FDA PDF
Indication
Dogs: treatment of urinary tract infections (cystitis) caused by susceptible Staphylococcus pseudintermedius, Proteus mirabilis, Escherichia coli and Enterococcus faecalis, and skin and soft tissue infections (wounds and abscesses) caused by susceptible strains of listed organisms. Cats: treatment of skin infections (wounds and abscesses) caused by susceptible Staphylococcus aureus, Escherichia coli and Pasteurella multocida.
Dose regimen
1.1 to 3.4 mg/lb (2.5 to 7.5 mg/kg), oral (30 mg/mL suspension), once daily, dogs: skin infections 2-3 days beyond cessation of clinical signs for a maximum of 30 days, urinary tract infections at least 10 consecutive days; cats: 7.5 mg/kg (1 mL/kg) once daily
The dose of ORBAX Oral Suspension in the dog is 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/kg) of body weight administered once daily.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| cmax | 5.82 (oral suspension) vs 6.32 (tablets) | dogs, bioequivalence study 99378, single oral 7.5 mg/kg, fasted, n=24 Beagles, overall means; unit printed as g/mL (µ glyph lost); 90% CI bounds -13.66% / -2.13% | Cmax (g/mL) ORBAX Tablets 6.32 - 13.66 - 2.13 ORBAX Oral Suspension 5.82 |
| auc | 54.62 (oral suspension) vs 55.19 (tablets) | dogs, AUClast, single oral 7.5 mg/kg, fasted, n=24; unit µg·hr/mL; 90% CI bounds -6.68% / +4.61% | AUClast (g hr/mL) ORBAX Tablets 55.19 - 6.68 + 4.61 ORBAX Oral Suspension 54.62 |
| other | equal to or less than 1.30 | dogs, ratio AUC0-T (steady state) / AUC0-24 (first dose) across 7.5-75 mg/kg/day groups in the 30-day TAS study; indicates minimal accumulation | The ratio of area under the curve (AUC) values estimated at steady state (AUC 0-T) versus after the first dose (AUC0-24) was equal to or less than 1.30 across the four dosing groups, indicating that minimal drug accumulation occurred with a once daily dosing regimen. |
| cmax | 2.9 (1.4) µg/mL | cats, study 99379, single oral suspension 7.5 mg/kg fasted, n=24 crossover vs tablet; row columns: AUC0-last, AUC0-inf, Cmax, Tmax (range), T½ (SD) | Suspension 26.7 (8.4) 30.4 (7.7) 2.9 (1.4) 1.8 (0.5-8.0) 6.2 (2.4) |
| auc | 26.7 (8.4) µg*hr/mL | cats, AUC0-last, single oral suspension 7.5 mg/kg fasted (study 99379); tablet AUC0-last 33.0 (8.9) | Suspension 26.7 (8.4) 30.4 (7.7) 2.9 (1.4) 1.8 (0.5-8.0) 6.2 (2.4) |
| half-life | 6.2 (2.4) hr | cats, harmonic mean terminal half-life, single oral suspension 7.5 mg/kg fasted (study 99379) | Suspension 26.7 (8.4) 30.4 (7.7) 2.9 (1.4) 1.8 (0.5-8.0) 6.2 (2.4) |
| auc | 42.1 (15.1) µg*hr/mL fed vs 31.6 (8.3) fasted | cats, AUC0-inf, study 35714 fed/fasted crossover, 7.5 mg/kg suspension, n=6; fed row columns AUC0-last, AUC0-inf, Cmax, Tmax, T½ | Fed 37.3 (14.5) 42.1 (15.1) 3.4 (1.3) 3.8 (1.0-8.0) 8.04 (3.5) Food leads to a slight increase in the bioavailability of ORBAX Oral Suspension in most cats. Fasted 26.4 (5.7) 31.6 (8.3) 3.0 (0.6) 1.6 (0.5-3.0) 9.43 (2.4) |
| protein binding | ~18% | feline plasma, in vitro ultrafiltration at 0.1-10 µg/mL (17.3-18.8%) | ORBAX (orbifl oxacin) Oral Suspension has low protein binding (~18%) in feline plasma. |
Target-animal safety
dose multiples 1X, 3X, 5X, 10X; duration 30 consecutive days at 7.5, 22.5 and 37.5 mg/kg/day (1X, 3X, 5X); 10 consecutive days at 75 mg/kg/day (10X, by gavage); placebo control 10 dogs; animals 50.
Animals: Fifty (50) healthy, Beagle dogs (25 males and 25 females). The dogs were at least 9 months of age and weighed between 6.8 and 14.5 kg at the time of initiation of dosing.
| Finding | Quote |
|---|---|
| Fecal discoloration at all doses; vomiting and soft/mucoid feces at 37.5 and 75 mg/kg/day. | Discoloration of the feces was observed at all dose levels. At 37.5 and 75 mg/kg/day, ORBAX Oral Suspension caused gastrointestinal signs, including vomiting and soft and/or mucoid feces. |
| At 75 mg/kg/day: hypersalivation, reduced food consumption and mild weight loss (males), glucosuria and lowered urine pH. | At doses of 75 mg/kg/day, hypersalivation was observed. Male dogs treated with 75 mg/kg/day had reduced food consumption and mild weight loss. Glucosuria and lowered urine pH were also observed in dogs treated with orbifloxacin at 75 mg/kg/day. |
| One 10X male developed hepatic perilobular necrosis and bile duct hyperplasia with elevated bilirubin and liver enzymes after 10 days at 75 mg/kg/day. | Following ten days of treatment with 75 mg/kg/day, one male dog developed hepatic perilobular necrosis and bile duct hyperplasia and inflammation which were associated with serum elevations in bilirubin and hepatic enzymes (ALP, ALT, AST, and GGT). |
| Articular cartilage defects in one 3X and one 5X male were judged long-standing and pre-existing. | Articular cartilage defects were observed in the head of the humerus in one male dog in the 3X dose group, and in the medial condyle of the distal femur in one male in the 5X dose group. Based on microscopic examination of these lesions, it was determined that both lesions were long-standing and were present prior to treatment with orbifloxacin. |
| Conclusion: dogs tolerated doses up to 37.5 mg/kg/day. | Dogs tolerated or ally administered ORBAX Oral Suspension at doses up to 37.5 mg/kg/day. |
| Cat 30-day study (2X, 6X, 10X): retinal hyperreflectivity indicative of central retinal degeneration at 6X and 10X by Day 24, with photoreceptor lesions on histopathology. | By Day 24 of treatment, lesions of hyperreflectivity indicative of central retinal degeneration were seen in multiple animals in the 6X and 10X dose groups. |
Effectiveness
Dogs: bioequivalence study 99378, randomized two-period two-sequence crossover of ORBAX Oral Suspension vs ORBAX Tablets at 7.5 mg/kg single oral dose, fasted, 14-day washout; effectiveness relies on the tablet field studies (NADA 141-081). Cats: PK-PD assessment (free AUC/MIC targets) of a 7.5 mg/kg suspension dose across 41 cats from three PK studies plus a 101-cat field palatability study; n = 24; primary endpoint: Bioequivalence: 90% confidence limits for Cmax and AUClast within +/-20% (untransformed) or 80-125% (log-transformed); result: Bioequivalent: 90% confidence limits for Cmax and AUClast within +/-20%; AUC and AUC/dose also within bounds; no adverse reactions. Cats: at least 90% of cats met PK-PD targets (AUC/MIC > 40 hr for S. aureus and P. multocida, > 100 hr for E. coli) so 7.5 mg/kg suspension judged as effective as 2.5 mg/kg tablets; palatability acceptance 95% (96/101) in cats and 96.3% (78/81) in dogs
Test Animals: Twenty-four (24) healthy, Beagle dogs (12 males and 12 females) approximately 11 months to 3 years of age and ranging in weight from 10 to 19 kg
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| No adverse reactions in the dog bioequivalence study | Accordingly, the data confirm that the ORBAX Oral Suspension formulation is bioequivalent to ORBAX Tablets in dogs. No adverse reactions were observed during this study. | ||
| Emesis and ventral abdominal hyperemia were not reported here; dog palatability study Day 0 acceptance (not an adverse reaction) | 98.8% (80/81) | For the Day 0 palatability assessment by the treatment administrator, 98.8% (80/81) of dogs treated with ORBAX Oral Suspension demonstrated acceptance. |
Extraction notes: Dual-species original approval (2010): the summary has a feline General Information section ('Species/Class: Cats') followed by 'IV. GENERAL INFORMATION: DOGS' ('Species/Class(es): Dogs'); the parser captured only the cat section. Dog fields are prioritised here (dose regimen, TAS margin-of-safety study 99548, BE study 99378); cat PK, PK-PD and TAS findings are labelled as such. The dog indication quote is truncated at a page break ('...in dogs caused by'); the remaining organisms are Staphylococcus pseudintermedius, S. aureus, coagulase positive staphylococci, Pasteurella multocida, Proteus mirabilis, Pseudomonas spp., Klebsiella pneumoniae, E. coli, Enterobacter spp., Citrobacter spp., Enterococcus faecalis, beta-hemolytic streptococci (Group G) and Streptococcus equisimilis. Table 8 (dog BE) units use private-use glyphs for µ and the bullet, reproduced verbatim in the quotes. Cat Table 2 rows are quoted whole; column order is AUC0-last, AUC0-inf, Cmax, Tmax (range), T½. The second adverse_reactions row is a palatability figure, not an adverse reaction; no adverse-reaction table exists for dogs in this summary. Cat 30-day TAS (study 99549, n=32, 2X/6X/10X) also found vomiting/hypersalivation at 6X-10X and albumin decreases; a 1X ocular study (n=16) found one cat with minimal focal retinal degeneration of unknown relation to treatment.
Orbax® Tablets NADA 141-081, Supplemental approval, September 18, 1997; sponsor Intervet, Inc.; species: Dogs and cats; foi_id 2063; FDA PDF
Indication
Management of diseases in dogs and cats associated with bacteria susceptible to orbifloxacin (this supplement adds the cat; clinical effectiveness in cats established for skin and soft tissue infections - wounds and abscesses).
Dose regimen
2.5 mg/kg, oral (tablet), once daily, 5 or 10 consecutive days in the feline field study; negligible accumulation supports a maximum 30-day duration of therapy
Under the conditions of this study ORBAX (brand of orbifloxacin) tablets administered once daily for five (5) or ten (10) consecutive days at a dose of 2.5 mg/kg body weight was safe and effective in the treatment of skin and soft tissue infections (wounds or abscesses) in cats.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| clearance | 3.98 mL/min/kg | cats, total body clearance/F after single oral 2.5 mg/kg ORBAX tablet (n=12, crossover with IV); dog column 3.02 ± 0.20 listed first; SD printed as ±.79 | Total body clearance/F, [mL/min/kg] 3.02 ± 0.20 3.98 ±.79 |
| cmax | 2.06 ug/mL | cats, single oral 2.5 mg/kg; dog value 2.33 ± 0.28 listed first; SD printed as ±.60 | Concentration maximum [Cmax (ug/mL)] 2.33 ± 0.28 2.06 ±.60 |
| tmax | 60 minutes (SD 27) | cats, single oral 2.5 mg/kg; dog value 46 ± 27 listed first | Time of maximum concentration [Tmax (minutes)] 46 ± 27 60 ±.27 |
| auc | 10.82 ug·h/mL (SD 2.6) | cats, AUC0-infinity after single oral 2.5 mg/kg; dog value 14.26 ± 1.4 listed first | Area under the curve [AUC0-ºº (ug·h/mL)] 14.26 ± 1.4 10.82 ±.2.6 |
| half-life | 5.52 hrs (SD 2.66) | cats, terminal plasma elimination half-life, single oral 2.5 mg/kg; dog value 5.6 listed first (SD garbled as 0.1.1) | Terminal plasma elimination half-life [t1/2 (hrs)] 5.6 ± 0.1.1 5.52 ±.2.66 |
| other | 1.03 | drug accumulation index (R) in cats, from single dose study P-6063; dog value 1.04 | Drug accumulation index (R) 1.04 1.03 |
| bioavailability | Essentially 100% | cats (and dogs), oral tablet vs IV, 2.5 mg/kg | Bioavailability (F) Essentially 100% Essentially 100% |
Target-animal safety
dose multiples 1X, 3X, 5X; duration 30 days (1X, 3X, 5X of the highest recommended dose 7.5 mg/kg, i.e. 7.5, 22.5, 37.5 mg/kg/day); separate kitten study 31-32 days at up to 9.2-25.3 mg/kg/day; animals 16 male and 16 female.
Thirty-two young adult (13 to 17 months old) domestic short-hair b. cats (16 male and 16 female) weighing 4.69 to 4.79 kg (mean of males) and 3.00 to 3.16 kg (mean of females) at study initiation were randomly allotted into 4 groups consisting of 4 males and 4 females in each of the control, low-, mid- and high-dose groups.
| Finding | Quote |
|---|---|
| Mild gastrointestinal effects (soft feces) at 22.5 and 37.5 mg/kg/day in both sexes. | Clinical Observations: Higher doses (22.5 and 37.5 mg/kg/day of orbifloxacin) caused mild gastrointestinal effects (soft feces) in both males and females. |
| Slightly but significantly decreased weight gain with decreased feed consumption in females at 37.5 mg/kg. | Slight, but significantly decreased weight gains accompanied by slightly decreased feed consumption were noted in female cats that received 37.5 mg/kg of orbifloxacin. |
| Rectal temperature, heart and respiratory rates unaffected; no adverse clinical or post-mortem pathologic findings. | heart rate and respiratory rate were unaffected by treatment. No adverse responses were seen on clinical, or post-mortem pathologic examination. |
| Conclusion: no adverse effects at 7.5 mg/kg/day for 30 days; only minimal toxic effects up to 5X (37.5 mg/kg). | There were only minimal toxic effects at doses up to five (5) times (37.5 mg/kg) the maximum clinical dose when administered for thirty (30) days. |
| Kitten study (12-week-old): limited transient soft stool in all treated groups, generally days 1-2; no adverse systemic effects at 7.5 mg/kg/day for 31-32 days. | Minor adverse clinical findings were noted. Limited, transient occurrence of soft stool occurred in all groups treated with ORBAX. These generally occurred on days 1 or 2. |
Effectiveness
Multi-center, blinded, positive-controlled (BAYTRIL enrofloxacin 2.5 mg/kg BID) clinical field study of dermal infections (wounds and abscesses) in cats; ORBAX 2.5 mg/kg orally once daily for 5 or 10 days; 7 investigators in 6 states, 5 contributing to the efficacy analysis; n = 91 cats evaluated for efficacy (44 ORBAX, 47 BAYTRIL) of 175 enrolled; primary endpoint: Wounds/abscesses healed by Day 11 (treatment success) and bacterial elimination; result: ORBAX 38/44 (86%) healed by Day 11 (exact 95% CI 72.6% to 94.8%) vs BAYTRIL 43/47 (91%) (79.6% to 97.6%); both treatments eliminated 100% of the most common bacteria; study not powered to detect differences between treatments
A total of 175 cases were enrolled in the study. Of these, 149 (85%) were domestic-long-hair or short-hair cats. Due to negative bacteriologic cultures, protocol violations and insufficient case load per investigator, 91 cases were evaluated for clinical efficacy (n = 44 in the ORBAX group, n = 47 in the BAYTRIL™ (enrofloxacin) tablet treated group.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting (mild, day 3, treatment discontinued; relation to drug undetermined) - feline field study | 1/82 | One cat in the ORBAX treated group (1/82) developed a mild degree of vomition on the third day of treatment. |
Extraction notes: Supplemental approval (1997) adding cats to NADA 141-081; all studies in this summary are in cats (dog PK values are shown alongside for comparison in Table 1 and come from the original dog approval). Species stated in the CFR conditions of use as 'Dogs and cats'; no Species/Class field in General Information. The schema field n_dogs holds feline counts here. The TAS design quote contains an extraction artefact ('short-hair b. cats') and spells the group size out (Thirty-two), so n_animals is given as '16 male and 16 female'. Table 1 SDs are printed with stray periods (e.g. '±.79'); values reported without those SDs where the number could not be matched verbatim.
Reproduce: foi_structured_search(query="Orbifloxacin") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).