Marbofloxacin: what the FDA reviewed for dog products
5 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Marbofloxacin, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Cats; Dogs; Dogs and cats.
Products
- Marbofloxacin (NADA/ANADA 200-736)
- Marbofloxacin Chewable Tablets (NADA/ANADA 200-733)
- Marboquin™ (NADA/ANADA 200-586)
- Zeniquin® (NADA/ANADA 141-151)
Zeniquin® NADA 141-151, Supplemental approval, August 01, 2001; sponsor Zoetis Inc.; species: Cats; foi_id 668; FDA PDF
Indication
Supplement provides for use in cats: treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin (feline effectiveness shown in skin and soft tissue infections).
Dose regimen
1.25 mg/lb body weight (may be increased to 2.5 mg/lb), oral (25 mg tablet labeled for cats), once daily, skin and soft tissue infections: 2-3 days beyond cessation of clinical signs, maximum 30 days; urinary tract infections: at least 10 days
Zeniquin tablets should be administered orally to dogs and cats at a dosage of 1.25 mg/lb of body weight once daily, but the dosage may be increased to 2.5 mg/lb.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | AUC0-inf 70 ± 6 µg•h/mL | single oral dose 2.5 mg/lb (5.5 mg/kg), 7 male cats, mean ± SD | AUC0 to inf (µg•h/mL) 70 ± 6 |
| cmax | 4.8 ± 0.7 µg/mL | single oral dose 2.5 mg/lb, n=7 cats | Cmax (µg/mL) 4.8 ± 0.7 |
| tmax | 1.2 ± 0.6 h | single oral dose 2.5 mg/lb, n=7 cats | Tmax (h) 1.2 ± 0.6 |
| half-life | 12.7 ± 1.1 h (t1/2 β) | single oral dose 2.5 mg/lb, n=7 cats | t1/2 β (h) 12.7 ± 1.1 |
| other | steady state after the third dose, ~35% above single-dose levels | predicted from half-life and once-daily dosing interval | Based on the terminal elimination half-life and the dosing interval, steady-state levels are reached after the third dose and are expected to be approximately 35% greater than those achieved after a single dose. |
Target-animal safety
dose multiples 1X, 3X, 5X; duration once daily for 42 days (2.5, 7.5, 12.5 mg/lb) in cats approximately 8 months of age.
Thirty-two cats approximately eight months of age, weighing 2.6 to 4.3 kg, were randomly allocated to four treatment groups containing four males and four females each.
| Finding | Quote |
|---|---|
| Salivation and redness/scabbing of ear pinnae in some high-dose (12.5 mg/lb) cats. | Treatment-related clinical findings observed during the course of the study consisted of varying degrees of salivation, and redness and scabbing of ear pinnae in some high-dose (12.5 mg/lb) animals. |
| No lameness; no body weight or ophthalmic effects; segmented neutrophil counts significantly lower in all marbofloxacin groups vs placebo (p<0.10). | Lameness evaluations did not reveal any clinical evidence of lameness in any cat. There were no changes in mean body weight or body weight gain data that could be attributed to treatment with marbofloxacin. |
| Macroscopic articular cartilage erosions of the distal femur in 3/8 high-dose and 1/8 mid-dose cats; microscopic chondropathy also in one 2.5 mg/lb cat. | Macroscopic articular cartilage erosions of the distal femur were detected in three of eight high-dose (12.5 mg/lb) and one of eight mid-dose (7.5 mg/lb) animals. |
| Conclusion: cartilage changes at 7.5 and 12.5 mg/lb for 42 days in 8-month-old cats, and histopathological change in one cat at 2.5 mg/lb; eosinophilic dermatitis in females at 7.5 and 12.5 mg/lb. | Gross and histopathological changes in the articular cartilage were produced when cats approximately eight months of age were administered marbofloxacin orally at 7.5 and 12.5 mg/lb for 42 days. Histopathological changes to articular cartilage were also seen in one cat receiving 2.5 mg/lb daily (1X the upper end of the dose range). |
| Follow-up study in skeletally mature (12-14 month) cats at 1.25, 3.75 and 7.5 mg/lb for 42 days: no cartilage or other tissue changes. | No gross or histopathological changes in articular cartilage or other tissues were produced by treatment of skeletally mature cats with marbofloxacin administered orally at 1.25, 3.75 and 7.5 mg/lb/day for 42 days. |
| Tolerance study at 25 mg/lb (10X) for 14 days: ptyalism, erythematous dermatitis, decreased food consumption, emesis; chondropathy in 2 of 6 treated cats, thymic lymphoid atrophy, GI mucosal lesions. | Clinical signs associated with drug intolerance were ptyalism, erythematous dermatitis, decreased food consumption, and emesis. Pathologic findings included perivascular to diffuse eosinophilic dermatitis, lymphoid atrophy of the thymus gland, articular chondropathy and abnormalities of the gastrointestinal mucosa. |
Effectiveness
Clinical field study MB-G-5002-94: masked, randomized, multi-site study in cats with naturally occurring skin and soft tissue bacterial infections; marbofloxacin 1.25 mg/lb or 2.5 mg/lb vs amoxicillin trihydrate 50 mg once daily for up to 14 days; 259 cats enrolled, 178 evaluable (80 at 1.25 mg/lb, 17 at 2.5 mg/lb, 81 amoxicillin; the 2.5 mg/lb arm was discontinued early).; primary endpoint: Complete clinical resolution of infection 5-7 days after end of therapy; result: 87.5% (70/80) resolved at 1.25 mg/lb, 82.4% (14/17) at 2.5 mg/lb, 87.7% (71/81) with amoxicillin; observed difference vs amoxicillin -0.2% (95% lower bound -8.7%) for 1.25 mg/lb.
Marbofloxacin administered orally to cats at 1.25 mg/lb once daily for up to 14 days was safe and effective in the treatment of bacterial infections of skin and soft tissue.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Diarrhea (field study; marbofloxacin 1.25 mg/lb n=115 vs amoxicillin n=113 enrolled cats) | 3 | 4 | Of the cases treated with 1.25 mg/lb of marbofloxacin, 6 cases had clinical signs possibly related to drug therapy. The following clinical signs were reported (number of cases in parenthesis): diarrhea (3), soft stool (2), vomiting (1). Of the cases treated with amoxicillin, 8 cases had clinical signs possibly related to drug therapy. The following clinical signs were reported: diarrhea (4), vomiting (3), decreased appetite, lethargy/decreased activity (1). |
| Vomiting (field study) | 1 | 3 | Of the cases treated with 1.25 mg/lb of marbofloxacin, 6 cases had clinical signs possibly related to drug therapy. The following clinical signs were reported (number of cases in parenthesis): diarrhea (3), soft stool (2), vomiting (1). Of the cases treated with amoxicillin, 8 cases had clinical signs possibly related to drug therapy. The following clinical signs were reported: diarrhea (4), vomiting (3), decreased appetite, lethargy/decreased activity (1). |
| Soft stool (field study) | 2 | The following clinical signs were reported (number of cases in parenthesis): diarrhea (3), soft stool (2), vomiting (1). | |
| No possibly related signs in the marbofloxacin 2.5 mg/lb group (31 enrolled cats) | There were no adverse clinical signs considered possibly related to drug therapy in the marbofloxacin 2.5 mg/lb treatment group. |
Extraction notes: This supplemental summary is for CATS (species_class 'Cats'); the application is listed under a dog product. n_dogs left null because the animals are cats (178 evaluable / 259 enrolled). Margin-of-safety study used 32 cats (four groups of 4 males + 4 females); n_animals null because '32' is spelled out. PK rows quoted as flattened table rows (n=7 cats, 2.5 mg/lb). Adverse reaction control counts refer to the amoxicillin comparator; 'treated' counts are cases in the 1.25 mg/lb group.
Marbofloxacin Chewable Tablets NADA 200-733, Original approval, January 12, 2023; sponsor Felix Pharmaceuticals Pvt. Ltd.; species: Dogs and cats; foi_id 13365; FDA PDF
Indication
Treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin (generic chewable version of Zeniquin, NADA 141-151).
Dose regimen
1.25 mg/lb body weight (may be safely increased to 2.5 mg/lb), oral (chewable tablet), once daily, skin and soft tissue infections: 2-3 days beyond cessation of clinical signs, maximum 30 days; urinary tract infections: at least 10 days
The recommended dosage for oral administration to dogs and cats is 1.25 mg marbofloxacin per lb of body weight once daily, but the dosage may be safely increased to 2.5 mg/lb.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 33044 ng/mL*hour (generic) vs 32364 (Zeniquin); ratio 1.02 (CI 1.00-1.04) | dogs, single 50 mg dose, fasted, crossover, 24 male Beagles, geometric means | AUC (ng/mL)*hour 33044† 32364† 1.02 1.00 1.04 |
| cmax | 2846 ng/mL (generic) vs 2621 ng/mL (Zeniquin); ratio 1.09 (CI 1.04-1.14) | dogs, single 50 mg dose, fasted, geometric means | CMAX (ng/mL) 2846† 2621† 1.09 1.04 1.14 |
| tmax | 1.11 (SD 0.30) hours (generic) vs 1.42 (0.38) hours (Zeniquin) | dogs, single 50 mg dose, fasted, arithmetic means | TMAX (hours) (SD‡) 1.11 (0.30)‡ 1.42 (0.38)‡ NE NE NE |
| auc | 40255 ng/mL*hour (generic) vs 39786 (Zeniquin); ratio 1.01 (CI 0.97-1.06) | cats, single 25 mg dose, fasted, crossover, 24 neutered male cats, geometric means | AUC (ng/mL)*hour 40255† 39786† 1.01 0.97 1.06 |
| cmax | 2865 ng/mL (generic) vs 2903 ng/mL (Zeniquin); ratio 0.99 (CI 0.91-1.07) | cats, single 25 mg dose, fasted, geometric means | CMAX (ng/mL) 2865† 2903† 0.99 0.91 1.07 |
| tmax | 2.13 (SD 1.88) hours (generic) vs 2.43 (2.08) hours (Zeniquin) | cats, single 25 mg dose, fasted, arithmetic means | TMAX (hours) (SD‡) 2.13 (1.88)‡ 2.43 (2.08)‡ NE NE NE |
Effectiveness
Bioequivalence (not effectiveness): randomized, masked, two-period, two-sequence, single-dose crossover blood-level study (GLP) of 50 mg generic chewable vs Zeniquin 50 mg tablets in 24 healthy fasted male dogs (7-day washout); parallel study of 25 mg tablets in 24 fasted cats; biowaiver for 25/100/200 mg dog strengths by dissolution (f2 55-66).; n = 24; primary endpoint: 90% CI of generic/RLNAD geometric mean ratios for CMAX and AUC within 0.80-1.25; result: Bioequivalent in dogs (AUC ratio 1.02, CMAX ratio 1.09) and cats (AUC 1.01, CMAX 0.99).
One in vivo blood-level study was conducted using the 50 mg tablet size in 24 healthy, fasted dogs.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| No serious adverse events (dog and cat bioequivalence studies) | There were no serious adverse events reported during the study. |
Extraction notes: Generic (ANADA) approval with a suitability petition for the chewable dosage form; no effectiveness or TAS studies. PK rows are flattened Table II.1/II.2 rows (columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI; TMAX columns are arithmetic mean (SD), NE = not estimated).
Marbofloxacin NADA 200-736, Original approval, January 13, 2023; sponsor ZyVet Animal Health, Inc.; species: Dogs and cats; foi_id 13375; FDA PDF
Indication
Treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin (generic of Zeniquin, NADA 141-151).
Dose regimen
1.25 mg/lb body weight (may be safely increased to 2.5 mg/lb), oral (tablet), once daily, skin and soft tissue infections: 2-3 days beyond cessation of clinical signs, maximum 30 days; urinary tract infections: at least 10 days
The recommended dosage for oral administration to dogs and cats is 1.25 mg marbofloxacin per lb of body weight once daily, but the dosage may be safely increased to 2.5 mg/lb.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 36452 ng/mL*hour (generic) vs 36290 (Zeniquin); ratio 1.004 (CI 0.966-1.045) | dogs, single 50 mg dose, fasted, crossover, 18 male dogs, geometric means | AUC (ng/mL)*hour 36452† 36290† 1.004 0.966 1.045 |
| cmax | 3022 ng/mL (generic) vs 3065 ng/mL (Zeniquin); ratio 0.986 (CI 0.949-1.025) | dogs, single 50 mg dose, fasted, geometric means | CMAX (ng/mL) 3022† 3065† 0.986 0.949 1.025 |
| tmax | 1.04 (SD 0.30) hours (generic) vs 1.16 (0.36) hours (Zeniquin) | dogs, single 50 mg dose, fasted, arithmetic means | TMAX (hours) (SD)‡ 1.04 (0.30)‡ 1.16 (0.36)‡ NE NE NE |
| auc | 37001.76 ng/mL*hour (generic) vs 39176.06 (Zeniquin); ratio 0.94 (CI 0.88-1.01) | cats, single 25 mg dose, fasted, crossover, 18 male cats, geometric means | AUC (ng/mL)*hour 37001.76† 39176.06† 0.94 0.88 1.01 |
| cmax | 2666.57 ng/mL (generic) vs 2895.26 ng/mL (Zeniquin); ratio 0.92 (CI 0.83-1.03) | cats, single 25 mg dose, fasted, geometric means | CMAX (ng/mL) 2666.57† 2895.26† 0.92 0.83 1.03 |
| tmax | 1.14 (SD 1.14) hours (generic) vs 0.87 (0.84) hours (Zeniquin) | cats, single 25 mg dose, fasted, arithmetic means | TMAX (hours) (SD)‡ 1.14 (1.14)‡ 0.87 (0.84)‡ NE NE NE |
Effectiveness
Bioequivalence (not effectiveness): masked, balanced, randomized, two-period, two-sequence, single-dose crossover blood-level study (GLP) of 50 mg generic vs Zeniquin 50 mg tablets in 18 healthy fasted male dogs (10-day washout); parallel study of 25 mg tablets in 18 fasted cats (9-day washout); biowaiver for 25/100/200 mg dog strengths by dissolution.; n = 18; primary endpoint: 90% CI of generic/RLNAD geometric mean ratios for CMAX and AUC within 0.80-1.25; result: Bioequivalent in dogs (AUC ratio 1.004, CMAX 0.986) and cats (AUC 0.94, CMAX 0.92).
One in vivo blood-level study was conducted using the 50 mg tablet in 18 healthy, fasted dogs.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| No serious adverse events (dog and cat bioequivalence studies) | There were no serious adverse events reported during the study. |
Extraction notes: Generic (ANADA) approval; no effectiveness or TAS studies. PK rows are flattened Table II.1/II.2 rows (columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI). The 50 mg vs 25 mg dissolution comparison failed f2 > 50 for both generic and RLNAD, so the biowaiver relied on 25 mg generic vs 25 mg RLNAD (f2 57.0) plus the cat in vivo study.
Zeniquin® NADA 141-151, Original approval, June 26, 1999; sponsor Zoetis Inc.; species: Dogs; foi_id 667; FDA PDF
Indication
Treatment of infections in dogs associated with bacteria susceptible to marbofloxacin; clinical effectiveness confirmed in skin and soft tissue infections and urinary tract infections (cystitis).
Dose regimen
1.25 mg/lb body weight (may be safely increased to 2.5 mg/lb), oral (tablet), once daily, skin and soft tissue infections: 2-3 days beyond cessation of clinical signs, maximum 30 days; urinary tract infections: at least 10 days; re-evaluate if no improvement within 5 days
tablets should be administered orally to dogs at a dosage of 1.25 mg/lb of body weight once daily, but the dosage may be safely increased to 2.5 mg/lb.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| tmax | 1.5 ± 0.30 h (low dose); 1.8 ± 0.3 h (high dose) | single oral tablet dose of 1.25 mg/lb (low) or 2.5 mg/lb (high), 6 beagles per group, mean ± SD; table columns low dose, high dose | Time of maximum concentration, Tmax (h) 1.5 ± 0.30 1.8 ± 0.3 |
| cmax | 2.0 ± 0.2 µg/mL (low dose); 4.2 ± 0.5 µg/mL (high dose) | single oral tablet dose of 1.25 mg/lb (low) or 2.5 mg/lb (high), n=6 per group | Maximum concentration, Cmax, (µg/mL) 2.0 ± 0.2 4.2 ± 0.5 |
| auc | AUC0-inf 31.2 ± 1.6 µg•h/mL (low dose); 64 ± 8 µg•h/mL (high dose) | single oral tablet dose of 1.25 mg/lb (low) or 2.5 mg/lb (high), n=6 per group | AUC0-inf (µg•h/mL) 31.2 ± 1.6 64 ± 8 |
| half-life | 10.7 ± 1.6 h (low dose); 10.9 ± 0.6 h (high dose) | terminal plasma elimination half-life, single oral tablet dose of 1.25 mg/lb (low) or 2.5 mg/lb (high), n=6 per group | Terminal plasma elimination half-life, t1/2 (h) 10.7 ± 1.6 10.9 ± 0.6 |
| clearance | 94 ± 8 mL/h•kg | single IV dose of 2.5 mg/lb marbofloxacin 10% solution, 6 beagles | Total body clearance, (mL/h•kg) 94 ± 8 |
| other | Vss 1.19 ± 0.08 L/kg | volume of distribution at steady state, single IV dose 2.5 mg/lb, n=6 | Volume of distribution at steady state, Vss, (L/kg) 1.19 ± 0.08 |
| half-life | 9.5 ± 0.7 h | terminal elimination half-life after single IV dose 2.5 mg/lb, n=6 | Terminal plasma elimination half-life, t1/2, (h) 9.5 ± 0.7 |
| bioavailability | 94% absolute oral bioavailability | oral tablets vs IV in the same animals, fasted | The absolute bioavailability following dosing of oral tablets to the same animals was 94%. |
Target-animal safety
dose multiples 1x, 3x, 5x; duration once daily for 6 weeks (2.5, 7.5, 12.5 mg/lb = 1x, 3x, 5x the upper limit of the clinically effective dose).
To evaluate the safety of marbofloxacin in dogs when administered at 1x, 3x, or 5x the upper limit of the clinically effective dosage for 6 weeks.
| Finding | Quote |
|---|---|
| Vomiting, reddened skin (ears) and reddened mucous membranes seen in all groups incl. controls, most frequently at 5x; no clinical lameness; food consumption reduced at 3x/5x in week 1. | Vomiting, reddened skin (usually involving the ears) and reddened mucous membranes were occasionally observed in all groups, including controls, but were noted most frequently in the 5x group. No clinical lameness was noted in any of the treated animals. |
| Significant first-week weight loss of 4.8% (3x) and 7.7% (5x). | Dogs in the 3x and 5x treatment groups e xperienced significant weight losses of 4.8% and 7.7%, respectively, during the first week of treatm |
| Moderately lower serum total protein (albumin and globulin) at 3x and 5x, means within normal limits. | Marbofloxacin treatment was associated with m oderately lower serum total protein for animals in the 3x and 5x treatment groups. The change in total protein resulted from mild reductions in both albumin and globulin, with mean values remaining within normal limits. |
| Minimal to slight articular cartilage lesions in 1/8 placebo and 3/8 5x dogs, similar to controls and not typical of fluoroquinolone lesions. | Minimal to slight lesions in the articular cartilage were observed in 1/8 placebo-treated animals and in 3/8 animals given the 5x dose. |
| Conclusion of the margin-of-safety study. | Oral administration of marbofloxacin tablets to dogs at the maximum intended dose of 2.5 mg/lb produced no significant adverse reactions in young adult (12-14 month) beagle dogs. |
| Tolerance study at 25 mg/lb (10x) for 12 days: markedly reduced food intake, vomiting, dehydration, erythema/facial swelling; no significant or irreversible pathology. | Administration of marbofloxacin at 25 mg/lb (10x the upper limit of the clinically effective dose) for 12 days was associated with markedly reduced food intake, vomiting, dehydration and sporadic erythema and/or facial swelling. |
| Exploratory study in 3-4 month old large-breed puppies at 2x (5 mg/lb) for 14 days: articular cartilage lesions typical of fluoroquinolones, lameness in all treated dogs. | Administration of marbofloxacin at 2x the upper limit of the clinically effective dosage to rapidly growing 3-4 month old mongrel puppies was not well tolerated due to articular cartilage lesions typical of those seen with fluoroquinolone antimicrobial agents. |
Effectiveness
Clinical field study MB-G-5000-94: blinded, controlled, randomized multi-site study in client-owned dogs with bacterial skin and soft tissue infections; marbofloxacin 1.25 mg/lb or 2.5 mg/lb vs sulfadiazine/trimethoprim 12.0 mg/lb once daily for 5-14 days; 196 enrolled, 163 evaluable.; n = 50 (marbofloxacin 1.25 mg/lb group; 56 at 2.5 mg/lb; 57 SDZ/TMP); primary endpoint: Complete clinical resolution of the infection; result: 80.0% healed at 1.25 mg/lb (40/50), 76.8% at 2.5 mg/lb (43/56), 82.5% with SDZ/TMP (47/57). Separate UTI field study (MB-G-5001-94, 87 evaluable dogs): microbiological cure 97.2% vs 95.3% (SDZ/TMP).
Marbofloxacin 1.25 mg/lb 50 40 80.0 % Marbofloxacin 2.5 mg/lb 56 43 76.8% SDZ/TMP 57 47 82.5%
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Lethargy (UTI field study; 9 of 73 marbofloxacin-treated dogs had signs) | 5 | The following clinical signs were reported (number of cases in parenthesis): lethargy (5), vomiting (2), ataxia (1), decreased appetite (1), shaking (1), and soft stool (1). | |
| Vomiting (UTI field study) | 2 | The following clinical signs were reported (number of cases in parenthesis): lethargy (5), vomiting (2), ataxia (1), decreased appetite (1), shaking (1), and soft stool (1). | |
| Decreased appetite (skin/soft tissue field study; 60 dogs at 1.25 mg/lb and 71 at 2.5 mg/lb enrolled) | 8 | The following clinical signs were reported (number of cases in parenthesis): decreased appetite (8), vomiting (4), lethargy (4), anorexia (2), increased thirst (2), diarrhea (1), increased sexual aggressiveness (1), nervousness | |
| Vomiting (skin/soft tissue field study) | 4 | The following clinical signs were reported (number of cases in parenthesis): decreased appetite (8), vomiting (4), lethargy (4), anorexia (2), increased thirst (2), diarrhea (1), increased sexual aggressiveness (1), nervousness | |
| Lethargy (skin/soft tissue field study) | 4 | The following clinical signs were reported (number of cases in parenthesis): decreased appetite (8), vomiting (4), lethargy (4), anorexia (2), increased thirst (2), diarrhea (1), increased sexual aggressiveness (1), nervousness | |
| Seizure (one dog with a seizure the day before enrollment) | One dog which had a seizure the day before study enrollme nt experienced a seizure while on marbofloxacin therapy. |
Extraction notes: The PDF text has frequent split words (e.g. 'm arbofloxacin', 'Zeni quin', 'e xperienced', 'treatm ent'), so several quotes are truncated just before or reproduce such artifacts. Indication quote is truncated before 'm arbofloxacin'. PK table rows quoted as flattened rows (columns: 1.25 mg/lb, 2.5 mg/lb). Margin-of-safety study used 32 beagles (four groups of 4 males + 4 females), but n_animals is null because the count is spelled out; the 10x tolerance study (12 dogs, 12 days) and 2x puppy study (16 puppies, 14 days) are included as findings. Adverse-reaction counts in the field studies are case counts of possibly related signs, not per-group percentages; control (SDZ/TMP) counts were not reported.
Marboquin™ NADA 200-586, Original approval, March 23, 2020; sponsor Dechra Veterinary Products LLC; species: Dogs and cats; foi_id 8507; FDA PDF
Indication
Treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin (generic of Zeniquin, NADA 141-151).
Dose regimen
1.25 mg/lb body weight (may be safely increased to 2.5 mg/lb), oral (tablet), once daily, skin and soft tissue infections: 2-3 days beyond cessation of clinical signs, maximum 30 days; urinary tract infections: at least 10 days
The recommended dosage for oral administration to dogs and cats is 1.25 mg marbofloxacin per lb of body weight once daily, but the dosage may be safely increased to 2.5 mg/lb.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | AUC0-Last 38292 ng/mL×hr (test) vs 36784 ng/mL×hr (Zeniquin); ratio 1.04 (CI 1.01-1.08) | dogs, single 50 mg tablet, fasted, two-period crossover, 20 dogs, geometric means | AUC0-Last (ng/mL×hr) 38292 36784 1.04 1.01 1.08 |
| cmax | 3377 ng/mL (test) vs 3233 ng/mL (Zeniquin); ratio 1.06 (CI 1.00-1.12) | dogs, single 50 mg tablet, fasted, geometric means | Cmax (ng/mL) 3377 3233 1.06 1.00 1.12 |
| tmax | 1.67 (SD 0.73) hr (test) vs 1.62 (0.73) hr (Zeniquin) | dogs, single 50 mg tablet, fasted, arithmetic means | Tmax (hr) (SD) 1.67 (0.73) 1.62 (0.73) |
| auc | AUC0-Last 81874 ng/mL×hr (test) vs 76152 ng/mL×hr (Zeniquin); ratio 1.07 (CI 1.02-1.12) | cats, single 25 mg tablet, fasted, crossover, 24 cats, geometric means | AUC0-Last (ng/mL×hr) 81874 76152 1.07 1.02 1.12 |
| cmax | 7165 ng/mL (test) vs 6736 ng/mL (Zeniquin); ratio 1.05 (CI 0.99-1.11) | cats, single 25 mg tablet, fasted, geometric means | Cmax (ng/mL) 7165 6736 1.05 0.99 1.11 |
| tmax | 0.97 (SD 0.40) hr (test) vs 1.09 (0.36) hr (Zeniquin) | cats, single 25 mg tablet, fasted, arithmetic means | Tmax (hr) (SD) 0.97 (0.40) 1.09 (0.36) |
Effectiveness
Bioequivalence (not effectiveness): randomized, two-sequence, two-period, single-dose crossover blood-level study of 50 mg generic vs Zeniquin 50 mg tablets in 20 fasted healthy dogs (7-day washout); parallel study of 25 mg tablets in 24 fasted cats; biowaiver for 25/100/200 mg dog strengths by dissolution (f2 51-84).; n = 20; primary endpoint: 90% CI of test/reference geometric mean ratios for AUC0-last and Cmax within 0.80-1.25; result: Bioequivalence demonstrated in dogs and cats; both AUC0-last and Cmax within acceptance limits.
The in vivo blood-level study was conducted in 20 healthy, fasted dogs. Bioequivalence was demonstrated between the 50 mg Zeniquin® (marbofloxacin) Tablet and the 50 mg Marboquin™ (marbofloxacin) Tablet by demonstrating that the confidence limits for the difference between the pivotal parameters CMAX and AUC are contained within the equivalence limits of 80.00% and 125.00%.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| No serious adverse events (dog and cat bioequivalence studies) | There were no serious adverse events reported during the study. |
Extraction notes: Generic (ANADA) approval: no effectiveness or TAS studies; the effectiveness field holds the bioequivalence study. PK rows are flattened Table II.1/II.2 rows (columns: test mean, reference mean, ratio, lower 90% CI, upper 90% CI). Data from 1 dog in period 1 and 3 dogs in period 2 were discarded for dosing failures.
Reproduce: foi_structured_search(query="Marbofloxacin") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).