Maropitant citrate: what the FDA reviewed for dog products
5 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Maropitant citrate, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs; Dogs and Cats.
Products
- Cerenia® Injectable Solution (NADA/ANADA 141-263)
- Maropitant Citrate (NADA/ANADA 200-747)
- Maropitant Citrate Tablets (NADA/ANADA 200-785)
- Maropitant Citrate Tablets (NADA/ANADA 200-833)
Cerenia® Injectable Solution NADA 141-263, Supplemental approval, January 11, 2016; sponsor Zoetis Inc.; species: Dogs and Cats; foi_id 821; FDA PDF
Indication
Prevention and treatment of acute vomiting in dogs (this supplement adds the intravenous route for dogs and cats and clarifies timing before emetogenic medications in dogs)
Dose regimen
1 mg/kg (0.45 mg/lb), intravenous over 1-2 minutes or subcutaneous, once daily, Up to 5 consecutive days (dogs 4 months and older); single dose 45-60 minutes before emetogenic medications or chemotherapy; dogs 2-4 months of age: subcutaneous only
Dogs 4 months of Age and Older: Administer CERENIA Injectable Solution intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/1 kg (1 mL/22 lb) of body weight once daily for up to 5 consecutive days.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| bioavailability | 109% (SC absolute bioavailability) | 1.0 mg/kg IV vs SC crossover, 8 Beagles, not fasted | The bioavailability of the SC route of administration exceeded 100% (109%), which could be attributable to the inherent variability of maropitant and/or an underestimation of the extrapolated initial concentration of the IV route of administration. |
| cmax | 296.62 ng/mL (IV) | 1.0 mg/kg single dose, 8 Beagle dogs (4M/4F), two-period crossover IV vs SC, not fasted; flattened Table 4 row order: Cmax (ng/mL), Tmax (hr), AUClast (hr*ng/mL), AUCinf (hr*ng/mL), half-life (hr, harmonic mean, marked 'a'), Vdss (L/kg), CL (mL/hr/kg); mean (SD) | IV 296.62 (60.77) n/a 675.40 (139.94) 693.83 (137.25) 6.85a (2.13) 9.63 (2.53) 1499.13 (345.40) |
| auc | 675.40 hr*ng/mL (AUClast, IV) | 1.0 mg/kg single dose, 8 Beagle dogs (4M/4F), two-period crossover IV vs SC, not fasted; flattened Table 4 row order: Cmax (ng/mL), Tmax (hr), AUClast (hr*ng/mL), AUCinf (hr*ng/mL), half-life (hr, harmonic mean, marked 'a'), Vdss (L/kg), CL (mL/hr/kg); mean (SD) | IV 296.62 (60.77) n/a 675.40 (139.94) 693.83 (137.25) 6.85a (2.13) 9.63 (2.53) 1499.13 (345.40) |
| half-life | 6.85 hr (IV, harmonic mean) | 1.0 mg/kg single dose, 8 Beagle dogs (4M/4F), two-period crossover IV vs SC, not fasted; flattened Table 4 row order: Cmax (ng/mL), Tmax (hr), AUClast (hr*ng/mL), AUCinf (hr*ng/mL), half-life (hr, harmonic mean, marked 'a'), Vdss (L/kg), CL (mL/hr/kg); mean (SD) | IV 296.62 (60.77) n/a 675.40 (139.94) 693.83 (137.25) 6.85a (2.13) 9.63 (2.53) 1499.13 (345.40) |
| clearance | 1499.13 mL/hr/kg (IV) | 1.0 mg/kg single dose, 8 Beagle dogs (4M/4F), two-period crossover IV vs SC, not fasted; flattened Table 4 row order: Cmax (ng/mL), Tmax (hr), AUClast (hr*ng/mL), AUCinf (hr*ng/mL), half-life (hr, harmonic mean, marked 'a'), Vdss (L/kg), CL (mL/hr/kg); mean (SD) | IV 296.62 (60.77) n/a 675.40 (139.94) 693.83 (137.25) 6.85a (2.13) 9.63 (2.53) 1499.13 (345.40) |
| other | Vdss 9.63 L/kg (IV) | 1.0 mg/kg single dose, 8 Beagle dogs (4M/4F), two-period crossover IV vs SC, not fasted; flattened Table 4 row order: Cmax (ng/mL), Tmax (hr), AUClast (hr*ng/mL), AUCinf (hr*ng/mL), half-life (hr, harmonic mean, marked 'a'), Vdss (L/kg), CL (mL/hr/kg); mean (SD) | IV 296.62 (60.77) n/a 675.40 (139.94) 693.83 (137.25) 6.85a (2.13) 9.63 (2.53) 1499.13 (345.40) |
| cmax | 102.99 ng/mL (SC) | 1.0 mg/kg single dose, 8 Beagle dogs (4M/4F), two-period crossover IV vs SC, not fasted; flattened Table 4 row order: Cmax (ng/mL), Tmax (hr), AUClast (hr*ng/mL), AUCinf (hr*ng/mL), half-life (hr, harmonic mean, marked 'a'), Vdss (L/kg), CL (mL/hr/kg); mean (SD) | SC 102.99 (46.06) 0.56 (.40) 733.11 (198.77) 759.08 (189.49) 8.84a (4.78) n/a n/a |
| tmax | 0.56 hr (SC) | 1.0 mg/kg single dose, 8 Beagle dogs (4M/4F), two-period crossover IV vs SC, not fasted; flattened Table 4 row order: Cmax (ng/mL), Tmax (hr), AUClast (hr*ng/mL), AUCinf (hr*ng/mL), half-life (hr, harmonic mean, marked 'a'), Vdss (L/kg), CL (mL/hr/kg); mean (SD) | SC 102.99 (46.06) 0.56 (.40) 733.11 (198.77) 759.08 (189.49) 8.84a (4.78) n/a n/a |
| auc | 733.11 hr*ng/mL (AUClast, SC) | 1.0 mg/kg single dose, 8 Beagle dogs (4M/4F), two-period crossover IV vs SC, not fasted; flattened Table 4 row order: Cmax (ng/mL), Tmax (hr), AUClast (hr*ng/mL), AUCinf (hr*ng/mL), half-life (hr, harmonic mean, marked 'a'), Vdss (L/kg), CL (mL/hr/kg); mean (SD) | SC 102.99 (46.06) 0.56 (.40) 733.11 (198.77) 759.08 (189.49) 8.84a (4.78) n/a n/a |
| half-life | 8.84 hr (SC, harmonic mean) | 1.0 mg/kg single dose, 8 Beagle dogs (4M/4F), two-period crossover IV vs SC, not fasted; flattened Table 4 row order: Cmax (ng/mL), Tmax (hr), AUClast (hr*ng/mL), AUCinf (hr*ng/mL), half-life (hr, harmonic mean, marked 'a'), Vdss (L/kg), CL (mL/hr/kg); mean (SD) | SC 102.99 (46.06) 0.56 (.40) 733.11 (198.77) 759.08 (189.49) 8.84a (4.78) n/a n/a |
| other | AUClast IV/SC geometric mean ratio 0.93 (90% CI 85.81-100.51%), bioequivalent | 1.0 mg/kg IV vs SC crossover, 8 Beagles | The IV route of administration resulted in a substantially higher Cmax, but the AUClast of both routes were bioequivalent (geometric treatment mean 0.93; 90% CI of 85.81- 100.51%). |
| cmax | 297 ng/mL (Day 0, low-dose IV group; 1040 in high-dose group) | 5-day IV safety study toxicokinetics at 1 mg/kg (T02) and 3 mg/kg (T03), 16-week-old Beagles, 8/group; flattened Table 8 row: maropitant 1 mg/kg, maropitant 3 mg/kg, metabolite CJ-18518 1 mg/kg, metabolite 3 mg/kg; mean (SD) | 0 Cmax ng/mL 297 (33.8) 1040 (232) 32.5 (22.9) 125 (39.0) |
| other | no significant accumulation after 5 consecutive daily IV doses | 1 and 3 mg/kg IV once daily for 5 days | There was no significant accumulation of maropitant or metabolite CJ 18518 after 5 consecutive daily IV doses of Cerenia Injectable Solution in both treatment groups. |
Target-animal safety
dose multiples 1X (1 mg/kg IV), 3X (3 mg/kg IV); duration 5 consecutive days, once daily IV bolus over 1-2 minutes, saline control, unmasked GLP; animals 24 (8 per group; 4 males and 4 females).
Purpose of Study: The objective was to evaluate the safety of CERENIA Injectable Solution (maropitant citrate) when administered intravenously at 1X and 3X the labeled dose for 5 consecutive days to Beagle dogs. The study focused on post-administration clinical signs, the route of administration, and bone marrow. b. Study Animals: The study included 24 healthy Beagle dogs (12 males and 12 females), aged 16 weeks old on study day 0. There were 8 dogs per treatment group (4 males and 4 females).
| Finding | Quote |
|---|---|
| All dogs survived | All dogs survived the study. |
| Sporadic diarrhea/soft stool in all groups; isolated vomiting (1 control, 1 at 1X) and injected sclera (1 at 3X) | There were sporadic incidences of diarrhea and soft stool in all groups. One male in group T01 and one female in group T02 vomited on study day 4. One female in group T03 had injected sclera on study day 2. |
| No effects on body weight or food consumption | There were no statistically significant or clinically relevant effects on body weight. |
| One 1X dog developed decreased WBC (neutropenia, leukopenia) and decreased hematocrit on day 5 | One male dog in group T02 had a normal complete blood count at acclimation, but a decreased white blood cell count (5.03 1000/µL, reference range 6.08-15.05 1000/µL) accompanied by a neutropenia and leukopenia and a decreased hematocrit (37.4%, reference range 37.5-52.8%) on study day 5. |
| No test-article histopathology; injection-site inflammation/hemorrhage secondary to IV procedure in all groups | There were no test-article associated abnormalities on histopathology. Dogs from all treatment groups had subacute inflammation and hemorrhage at injection sites that was secondary to the intravenous injection procedure. |
| Adequate safety profile for 1 mg/kg IV once daily for 5 days | The study results support an adequate safety profile for maropitant citrate when administered at 1 mg/kg by IV injection once daily for 5 consecutive days in dogs. |
Effectiveness
Laboratory, masked, saline-controlled study (#1961R-60-11-A81) of morphine-induced vomiting: CERENIA 1 mg/kg SC or saline given 45 minutes before morphine 0.5 mg/kg SC in 7-8-month-old dogs, 16 per group (8 males, 8 females); supports the timing claim for use before emetogenic medications; n = 16 per group; primary endpoint: Number of emetic events after morphine administration (up to 150 minutes into recovery); result: 0/16 CERENIA-treated dogs vomited vs 15/16 (93.8%) saline-treated dogs (p<0.05); no adverse reactions reported
Emetic Events: CERENIA Injectable Solution was significantly different from saline (p < 0.05) for prevention of morphine induced vomiting. No CERENIA Injectable Solution group dogs vomited, and 15 of 16 (93.8%) saline-treated dogs vomited at 5 or 10 minutes after morphine administration.
Extraction notes: Supplemental approval adding the IV route: no field study and no adverse-reaction table (the laboratory effectiveness study reports 'Adverse Reactions: None reported'). The effectiveness study supports the 45-minute pre-emetogen timing (SC), while the IV route is supported by IV/SC AUC bioequivalence. Cat PK and cat IV safety studies in the summary were not extracted. PK values come from flattened Table 4 and Table 8 rows (column order in conditions). Species_class kept as in the summary ('Dogs and Cats'); only dog data extracted.
Maropitant Citrate Tablets NADA 200-833, Original approval, January 12, 2026; sponsor Felix Pharmaceuticals Pvt. Ltd.; species: Dogs; foi_id 17886; FDA PDF
Indication
Prevention of acute vomiting and prevention of vomiting due to motion sickness in dogs.
Dose regimen
minimum 2 mg/kg (0.9 mg/lb) for acute vomiting; minimum 8 mg/kg (3.6 mg/lb) for motion sickness, Oral, once daily, acute vomiting: up to 5 consecutive days (dogs 2-7 months) or until resolution (7 months and older); motion sickness (4 months and older): up to 2 consecutive days
For Prevention of Acute Vomiting in dogs 2 - 7 months of age: Administer Maropitant Citrate Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days. For Prevention of Acute Vomiting in dogs 7 months of age and older: Administer Maropitant Citrate Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily until resolution of acute vomiting. For Prevention of Vomiting due to motion sickness in dogs 4 months of age and older: Administer Maropitant Citrate Tablets orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight once daily for up to 2 consecutive days.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | generic geometric mean 9213 vs RLNAD 9438 (ng/mL)*hour; ratio 0.98, CI 0.93 to 1.02 | bioequivalence study; single oral 60 mg chewable tablet vs Cerenia 60 mg tablet, fed, 26 dogs, two-period crossover; row columns: generic mean, RLNAD mean, ratio (test/reference), lower 90% CI, upper 90% CI | AUC (ng/mL)*hour 9213† 9438† 0.98 0.93 1.02 |
| cmax | generic geometric mean 690.8 vs RLNAD 742.1 ng/mL; ratio 0.93, CI 0.89 to 0.98 | same study; row columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI | CMAX (ng/mL) 690.8† 742.1† 0.93 0.89 0.98 |
| tmax | generic 2.0 (SD 0.60) hours vs RLNAD 1.8 (SD 0.63) hours (arithmetic means) | same study; no confidence interval estimated (NE) | TMAX (hours) (SD)‡ 2.0 (0.60)‡ 1.8 (0.63)‡ NE NE NE |
Effectiveness
NOT an effectiveness study: in vivo blood-level bioequivalence study, randomized, masked, two-period, two-sequence, single-dose crossover of generic 60 mg maropitant citrate chewable tablets vs Cerenia 60 mg tablets in fed dogs (14-day washout).; n = 26; primary endpoint: CMAX and AUC (90% CI of geometric mean ratio within 0.80-1.25); result: Bioequivalence demonstrated; no serious adverse events.
The in vivo blood-level study was conducted in 26 healthy, fed dogs.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| serious adverse events (bioequivalence study) | There were no serious adverse events reported during the study. |
Extraction notes: Generic (ANADA) approved under a suitability petition (FDA-2023-P-2155) because the generic is a chewable tablet while the RLNAD (Cerenia) is an oral tablet. Effectiveness and target animal safety studies not required; the effectiveness field holds the bioequivalence study, labelled as such. PK rows quote flattened rows of Table II.1 (column order in conditions). Biowaiver granted for 16, 24 and 160 mg strengths on dissolution data (>85% dissolved in 15 minutes, Table II.2).
Cerenia® Injectable Solution NADA 141-263, Original approval, January 29, 2007; sponsor Zoetis Inc.; species: Dogs; foi_id 818; FDA PDF
Indication
Prevention and treatment of acute vomiting in dogs
Dose regimen
1.0 mg/kg (0.45 mg/lb), i.e. 1.0 mL/10 kg of the 10 mg/mL solution, Subcutaneous injection, Once daily, For up to 5 consecutive days
Administer CERENIA Injectable Solution subcutaneously at 1.0 mg/kg (0.45 mg/lb) equal to 1.0 mL/10 kg (1.0 mL/22 lb) of body weight once daily for up to 5 consecutive days.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| other | SC 1 mg/kg gives Tmax, Cmax and AUC0 to 24 not statistically different from oral 2 mg/kg (no numeric values reported) | Crossover in 12 Beagles (6 per group), sampling 0.5-24 h | No statistical differences in the time to achieve maximum plasma concentration (Tmax), in maximum concentration (Cmax), or in area under the plasma concentration curve (AUC0 to 24) were detected between maropitant administered subcutaneously at a dosage of 1 mg/kg or orally at 2 mg/kg. |
Target-animal safety
dose multiples 0X (saline), 1X (1 mg/kg), 3X (3 mg/kg), 5X (5 mg/kg); duration Once daily subcutaneously for 15 days (Days 0-14); recovery groups observed to Day 36; animals Twenty-eight male and 28 female.
Purpose of the Study: To evaluate the safety of maropitant when administered to dogs subcutaneously once daily for 15 days at 0, 1, 3, and 5 mg/kg. 2. Description of Test Animals: Twenty-eight male and 28 female Beagle dogs were used in this study (a minimum of 16 weeks of age on Day 0).
| Finding | Quote |
|---|---|
| Well tolerated; all dogs gained weight | Maropitant injectable solution was well tolerated in all dogs. |
| Injection site lesions at necropsy: 1 dog at 1X, 4 dogs at 3X, 6 dogs at 5X | Injection site lesions were identified at necropsy in one dog at 1 mg/kg (1X), 4 dogs at 3 mg/kg (3X), and 6 dogs at 5 mg/kg (5X). |
| Injection site thickening in 6 dogs at 3X and 5 dogs at 5X | The other daily injection sites were found to be slightly thickened on 1 or more occasions in 6 dogs at 3 mg/kg (3X) and 5 dogs at 5 mg/kg (5X). |
| Prolonged APTT (67.5 s) in one 1X male dog, relationship undetermined | The activated partial thromboplastin time (APTT) was prolonged (67.5 seconds, reference range 9-15 seconds) in one male dog in the 1 mg/kg group on Study Day 15. |
| Conclusion: well tolerated in 16-week-old dogs up to 5 mg/kg for 15 days | Maropitant injectable solution (10 mg/mL) was well tolerated when administered subcutaneously to healthy 16-week-old dogs for 15 days at up to 5 mg/kg. |
| Separate study in 8-week-old puppies: increased frequency/severity of bone marrow hypoplasia at elevated doses | in this study with 8 week old puppies there was an increased frequency and greater severity of bone marrow hypoplasia reported for dogs treated with elevated doses of maropitant. |
| Not supported for use in puppies 8-11 weeks of age | The results of this study do not support the safe use of CERENIA in puppies 8-11 weeks of age. |
Effectiveness
Multi-site (30 US clinics), randomized (1 placebo : 3 maropitant), masked, placebo-controlled field study in client-owned dogs presenting with acute vomiting; SC 1 mg/kg on Day 0 then SC (1 mg/kg) or oral (2 mg/kg) once daily as needed up to Day 4; 275 dogs enrolled (206 maropitant, 69 placebo); n = 199 (145 maropitant, 54 placebo); primary endpoint: Evidence of vomiting (vomitus in cage or observed vomiting) during the study period; result: Vomiting at some time during the study in 21.4% (31/145) maropitant vs 50% (27/54) placebo dogs; Day 0 (SC) vomiting 10% vs 28%
Evidence of Vomiting: Of the 199 dogs included in the statistical summary of effectiveness, 27 of 54 dogs (50%) in the placebo group displayed vomiting at some time during the study and 31 of 145 dogs (21.4%) in the maropitant- treated group displayed vomiting during the study period.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Death during study | 4.9% (10/206) | 5.8% (4/69) | Placebo (n=69) Maropitant (n=206) Adverse Reaction # dogs % occur. # dogs % occur. Death during study 4 5.8 10 4.9 Euthanized during study 0 0 2 1.0 Diarrhea 6 8.7 8 3.9 Hematochezia/bloody stool 5 7.2 4 1.9 Anorexia 2 2.9 3 1.5 Otitis/Otorrhea 0 0 3 1.5 |
| Euthanized during study | 1.0% (2/206) | 0% (0/69) | Placebo (n=69) Maropitant (n=206) Adverse Reaction # dogs % occur. # dogs % occur. Death during study 4 5.8 10 4.9 Euthanized during study 0 0 2 1.0 Diarrhea 6 8.7 8 3.9 Hematochezia/bloody stool 5 7.2 4 1.9 Anorexia 2 2.9 3 1.5 Otitis/Otorrhea 0 0 3 1.5 |
| Diarrhea | 3.9% (8/206) | 8.7% (6/69) | Placebo (n=69) Maropitant (n=206) Adverse Reaction # dogs % occur. # dogs % occur. Death during study 4 5.8 10 4.9 Euthanized during study 0 0 2 1.0 Diarrhea 6 8.7 8 3.9 Hematochezia/bloody stool 5 7.2 4 1.9 Anorexia 2 2.9 3 1.5 Otitis/Otorrhea 0 0 3 1.5 |
| Hematochezia/bloody stool | 1.9% (4/206) | 7.2% (5/69) | Placebo (n=69) Maropitant (n=206) Adverse Reaction # dogs % occur. # dogs % occur. Death during study 4 5.8 10 4.9 Euthanized during study 0 0 2 1.0 Diarrhea 6 8.7 8 3.9 Hematochezia/bloody stool 5 7.2 4 1.9 Anorexia 2 2.9 3 1.5 Otitis/Otorrhea 0 0 3 1.5 |
| Anorexia | 1.5% (3/206) | 2.9% (2/69) | Placebo (n=69) Maropitant (n=206) Adverse Reaction # dogs % occur. # dogs % occur. Death during study 4 5.8 10 4.9 Euthanized during study 0 0 2 1.0 Diarrhea 6 8.7 8 3.9 Hematochezia/bloody stool 5 7.2 4 1.9 Anorexia 2 2.9 3 1.5 Otitis/Otorrhea 0 0 3 1.5 |
| Otitis/Otorrhea | 1.5% (3/206) | 0% (0/69) | Placebo (n=69) Maropitant (n=206) Adverse Reaction # dogs % occur. # dogs % occur. Death during study 4 5.8 10 4.9 Euthanized during study 0 0 2 1.0 Diarrhea 6 8.7 8 3.9 Hematochezia/bloody stool 5 7.2 4 1.9 Anorexia 2 2.9 3 1.5 Otitis/Otorrhea 0 0 3 1.5 |
Extraction notes: No numeric PK values are reported; the dosage-characterization PK statement is qualitative (SC 1 mg/kg ~ oral 2 mg/kg exposure). Effectiveness quoted from the pivotal clinical field study (#1467C-60-01-597); a second field study in cisplatin-treated cancer dogs (122 dogs) showed prevention of emesis in 94.9% (37/39) maropitant vs 4.9% (2/41) saline dogs, and two lab dose-confirmation studies (ipecac, apomorphine) were also positive. The pivotal study's minimum enrollment age was raised from 8 to 16 weeks after bone-marrow hypoplasia was seen in 8-week-old puppies in a separate TAS study. Adverse reactions from Table 4.5 (placebo n=69, maropitant n=206); n_animals given as 'Twenty-eight male and 28 female' because '56' is not in the quote.
Maropitant Citrate Tablets NADA 200-785, Original approval, June 17, 2024; sponsor Felix Pharmaceuticals Pvt. Ltd.; species: Dogs; foi_id 15545; FDA PDF
Indication
Prevention of acute vomiting and prevention of vomiting due to motion sickness in dogs.
Dose regimen
minimum 2 mg/kg (0.9 mg/lb) for acute vomiting; minimum 8 mg/kg (3.6 mg/lb) for motion sickness, Oral, once daily, acute vomiting: up to 5 consecutive days (dogs 2-7 months) or until resolution (7 months and older); motion sickness (4 months and older): up to 2 consecutive days
For Prevention of Acute Vomiting in dogs 2 -7 months of age: Administer Maropitant Citrate Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days. For Prevention of Acute Vomiting in dogs 7 months of age and older: Administer Maropitant Citrate Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily until resolution of acute vomiting. For Prevention of Vomiting due to motion sickness in dogs 4 months of age and older: Administer Maropitant Citrate Tablets orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight once daily for up to 2 consecutive days.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | generic geometric mean 7202 vs RLNAD 7404 (ng/mL)*hour; ratio 0.97, CI 0.94 to 1.01 | bioequivalence study; single oral 60 mg tablet, fed, 26 dogs, two-period crossover; row columns: generic mean, RLNAD mean, ratio (test/reference), lower 90% CI, upper 90% CI | AUC (ng/mL)*hour 7202† 7404† 0.97 0.94 1.01 |
| cmax | generic geometric mean 540 vs RLNAD 598 ng/mL; ratio 0.90, CI 0.84 to 0.97 | same study; row columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI | CMAX (ng/mL) 540† 598† 0.90 0.84 0.97 |
| tmax | generic 2.6 (SD 1.26) hours vs RLNAD 2.5 (SD 1.52) hours (arithmetic means) | same study; no confidence interval estimated (NE) | TMAX (hours) (SD)‡ 2.6 (1.26)‡ 2.5 (1.52)‡ NE NE NE |
Effectiveness
NOT an effectiveness study: in vivo blood-level bioequivalence study, randomized, masked, two-period, two-sequence, single-dose crossover of generic 60 mg maropitant citrate tablets vs Cerenia 60 mg tablets in fed dogs (14-day washout).; n = 26; primary endpoint: CMAX and AUC (90% CI of geometric mean ratio within 0.80-1.25); result: Bioequivalence demonstrated; no serious adverse events.
The laboratory study was conducted as a randomized, masked, two-period, two- sequence, two-treatment, single-dose crossover design using 26 healthy dogs with a 14-day washout between periods.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| serious adverse events (bioequivalence study) | There were no serious adverse events reported during the study. |
Extraction notes: Generic (ANADA); effectiveness and target animal safety studies not required. The effectiveness field holds the bioequivalence study, labelled as such. PK rows quote flattened rows of Table II.1 (column order in conditions; dagger = geometric mean). Biowaiver granted for 16, 24 and 160 mg strengths on dissolution data (>85% dissolved in <15 minutes).
Maropitant Citrate NADA 200-747, Original approval, March 31, 2023; sponsor ZyVet Animal Health, Inc.; species: Dogs; foi_id 13695; FDA PDF
Indication
Prevention of acute vomiting and prevention of vomiting due to motion sickness in dogs.
Dose regimen
minimum 2 mg/kg (0.9 mg/lb) for acute vomiting, Oral, once daily, up to 5 consecutive days in dogs 2-7 months of age; until resolution of acute vomiting in dogs 7 months and older. Motion sickness (dogs 4 months and older): minimum 8 mg/kg (3.6 mg/lb) once daily for up to 2 consecutive days.
For Prevention of Acute Vomiting in dogs 2 -7 months of age: Administer Maropitant Citrate tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days. For Prevention of Acute Vomiting in dogs 7 months of age and older: Administer Maropitant Citrate tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily until resolution of acute vomiting.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | generic geometric mean 8856.4 vs RLNAD 8669.7 (ng/mL)*hour; ratio 1.02, CI 1.00 to 1.05 | bioequivalence study; single oral 60 mg tablet, fed, 28 dogs, four-period replicate crossover; row columns: generic mean, RLNAD mean, ratio (test/reference), lower 90% CI, upper 90% CI | AUC (ng/mL)*hour 8856.4 8669.7 1.02 1.00 1.05 |
| cmax | generic geometric mean 781.3 vs RLNAD 779.6 ng/mL; ratio 1.00, CI 0.97 to 1.04 | same study; row columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI | CMAX (ng/mL) 781.3 779.6 1.00 0.97 1.04 |
| tmax | generic 1.86 (SD 0.64) hours vs RLNAD 1.71 (SD 0.55) hours (arithmetic means) | same study; no confidence interval estimated (NE) | TMAX (hours) (SD)‡ 1.86 (0.64)‡ 1.71 (0.55)‡ NE NE NE |
Effectiveness
NOT an effectiveness study: in vivo blood-level bioequivalence study, masked, randomized, four-period, two-sequence, single-dose replicate crossover of generic 60 mg maropitant citrate tablets vs Cerenia 60 mg tablets in fed dogs (7-day washout).; n = 28; primary endpoint: CMAX and AUC (average bioequivalence; 90% CI of geometric mean ratio within 0.80-1.25); result: Bioequivalence demonstrated; no serious adverse events.
The laboratory study was conducted as a randomized, masked, four-period, two- sequence, two-treatment, single-dose crossover design using 28 dogs with a 7-day washout between periods.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| serious adverse events (bioequivalence study) | There were no serious adverse events reported during the study. |
Extraction notes: Generic (ANADA); effectiveness and target animal safety studies not required. The effectiveness field holds the bioequivalence study, labelled as such. PK rows quote flattened rows of Table II.1 (column order given in conditions); 90% CI bounds are listed but the figure '90' is not in the row text. Biowaiver granted for 16, 24 and 160 mg strengths on dissolution data (>=85% dissolved in <15 minutes).
Reproduce: foi_structured_search(query="Maropitant citrate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).