Cefovecin sodium: what the FDA reviewed for dog products
2 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Cefovecin sodium, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs and cats; cats; Canine.
Products
- Cefovecin Sodium for Injection (NADA/ANADA 200-812)
- Convenia® (NADA/ANADA 141-285)
Convenia® NADA 141-285, Original approval, April 25, 2008; sponsor Zoetis Inc.; species: cats; Canine; foi_id 849; FDA PDF
Indication
Dogs: treatment of skin infections (secondary superficial pyoderma, abscesses, wounds) caused by susceptible Staphylococcus intermedius and Streptococcus canis (Group G). Cats: skin infections (wounds and abscesses) caused by susceptible Pasteurella multocida.
Dose regimen
3.6 mg/lb (8 mg/kg), Subcutaneous injection, single injection; a second injection may be given if response is incomplete (maximum 2 injections), therapeutic concentrations maintained 7 days for S. intermedius and 14 days for S. canis (Group G) infections; cats: single one-time injection, approximately 7 days for P. multocida
CONVENIA should be administered as a single subcutaneous injection of 3.6 mg/lb (8 mg/kg) body weight. A second subcutaneous injection of 3.6 mg/lb (8 mg/kg) may be administered if response to therapy is not complete.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| half-life | 133 h (harmonic mean; range 96, 206) | dogs, single SC 8 mg/kg, total drug, Study 5562N-36-99-210, n=6 first period | Terminal plasma elimination T (h)*H 133 (96, 206) |
| auc | 10400 ± 1900 µg·h/mL (geometric mean AUC0-inf) | dogs, single SC 8 mg/kg, total drug, first phase n=6 | AUC0-inf (µg·h/mL )*G 10400 ± 1900 p |
| tmax | 6.2 ± 3.0 h | dogs, single SC 8 mg/kg, total drug | Time to maximum concentration, Tmax (h)*H 6.2 ± 3.0 |
| cmax | 121 ± 51 μg/mL (arithmetic mean) | dogs, single SC 8 mg/kg, total drug | Maximum concentration, Cmax (μg/mL)*A 121 ± 51 |
| other | Vdss 0.122 ± 0.011 L/kg (geometric mean) | dogs, single IV 8 mg/kg | Vdss ( L/kg)**G 0.122 ± 0.011 |
| clearance | 0.76 ± 0.13 mL/h/kg (geometric mean; SD printed as .0.13) | dogs, single IV 8 mg/kg, first phase n=6 | CLtotal (mL/h/kg )**G 0.76 ± .0.13 p |
| protein binding | 96% to 98.7% | dog plasma, equilibrium dialysis, over 10 - 100 µg/mL total concentration range after single 8 mg/kg injection | The percent protein binding decreased in a nonlinear manner, ranging from 96% to 98.7% protein binding within the range of total plasma drug concentrations observed following a single 8 mg/kg injection to dogs (10 – 100 µg/mL). |
| half-life | 166 h (harmonic mean; range 147, 190) | CATS, single SC 8 mg/kg, total drug, Study 5582N-36-99-197, n=6 | Terminal plasma elimination T (h)*H 166 (147, 190) |
Target-animal safety
dose multiples 1.5X, 4.5X, 7.5X; duration Forty-two days; injections once every 7 days for a total of five injections (0, 12, 36, 60 mg/kg); animals Thirty-two (16M and 16F).
To evaluate the safety and injection site toleration of CONVENIA when administered subcutaneously once every 7 days for a total of five injections in dogs. b. Test Animals: Thirty-two healthy Beagle dogs (16M and 16F), approximately 4 months of age, were randomly assigned to the four dose groups.
| Finding | Quote |
|---|---|
| Injection site swellings increased with dose, usually appearing within one hour | Occurrences of injection site swellings increased with increasing doses of CONVENIA and usually appeared within one hour of administration. |
| Maximum injection site swelling 6 mm x 6 mm | The maximum swelling measured throughout the study was 6 mm X 6 mm (length X width). |
| Dose-related vomiting (1 control, 2 at 12 mg/kg, 3 at 36 mg/kg, 5 at 60 mg/kg) | There was one incidence of vomiting in the control group, two cases in the 12 mg/kg group, three in the 36 mg/kg group, and five cases in the 60 mg/kg group. |
| Mean WBC counts lower in all treated groups than control at several time points | The mean values for all the treated groups were statistically significantly lower than the control group at the first, third, fourth and fifth time points. |
| Higher mean bile acids in 12 and 60 mg/kg groups | The mean bile acid values for the 12 mg/kg group (p = 0.0899) and the 60 mg/kg group (p = 0.0040) were statistically significantly higher than that of the control group. |
| Mild hepatic and renal lesions in two 60 mg/kg dogs | Mild hepatic and renal lesions were observed in two of the 60 mg/kg group dogs. |
| Conclusion: adequate safety margin over 42 days | An adequate safety margin was demonstrated for CONVENIA when administered under the conditions of this study throughout the 42-day study duration. |
| Separate drug tolerance study, single SC 180 mg/kg (12 dogs, 6 treated): dogs remained healthy 30 days; transient injection site edema in treated and control dogs | Under the conditions of this study, the dogs remained healthy throughout the 30-day duration. Irritation following injection and transient injection site edema occurred in both the control and CONVENIA-treated dogs. The edema resolved within 24 hours. |
Effectiveness
Multi-center (26 practices, 13 states), masked, randomized, active-controlled non-inferiority field study (GCP) in dogs with naturally occurring skin infections: single SC CONVENIA 8 mg/kg (optional second injection at 14 days) vs oral cefadroxil 22 mg/kg for 14 days; per-protocol analysis, non-inferiority margin 15 percentage points; n = 320 enrolled (157 CONVENIA, 163 cefadroxil); 118 CONVENIA and 117 cefadroxil evaluable; primary endpoint: Successful treatment = each clinical sign initially moderate/severe reduced to mild or absent at final assessment (28 days after final treatment); result: CONVENIA 109 (92.4%) vs cefadroxil 108 (92.3%) successfully treated at final assessment; CONVENIA non-inferior to cefadroxil (delta = 0.15); veterinarian outcome cures 97 (82.2%) vs 98 (83.8%)
There were 320 dogs enrolled in the study. This included 157 CONVENIA cases and 163 cefadroxil cases. Eighty-five cases (85) were excluded from the effectiveness evaluation. The most common reason for exclusion was failure to confirm a viable isolate during bacterial identification and minimum inhibitory concentration testing. Other reasons for exclusion were failure to meet inclusion criteria, insufficient number of evaluable cases from a site, missing or incomplete microbiology data, and extreme scheduling deviations for the final assessment visit. The effectiveness evaluation was based on 118 CONVENIA-treated cases and 117 cefadroxil-treated cases.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting | 6/157 | 12/163 | CONVENIA n = 157 Cefadroxil n = 163 Lethargy 2 7 Anorexia/Decreased Appetite 5 8 Vomiting 6 12 Diarrhea 6 7 Blood in feces 1 2 Dehydration 0 1 Flatulence 1 0 Increased Borborygmi 1 0 |
| Diarrhea | 6/157 | 7/163 | CONVENIA n = 157 Cefadroxil n = 163 Lethargy 2 7 Anorexia/Decreased Appetite 5 8 Vomiting 6 12 Diarrhea 6 7 Blood in feces 1 2 Dehydration 0 1 Flatulence 1 0 Increased Borborygmi 1 0 |
| Anorexia/Decreased Appetite | 5/157 | 8/163 | CONVENIA n = 157 Cefadroxil n = 163 Lethargy 2 7 Anorexia/Decreased Appetite 5 8 Vomiting 6 12 Diarrhea 6 7 Blood in feces 1 2 Dehydration 0 1 Flatulence 1 0 Increased Borborygmi 1 0 |
| Lethargy | 2/157 | 7/163 | CONVENIA n = 157 Cefadroxil n = 163 Lethargy 2 7 Anorexia/Decreased Appetite 5 8 Vomiting 6 12 Diarrhea 6 7 Blood in feces 1 2 Dehydration 0 1 Flatulence 1 0 Increased Borborygmi 1 0 |
| Blood in feces | 1/157 | 2/163 | CONVENIA n = 157 Cefadroxil n = 163 Lethargy 2 7 Anorexia/Decreased Appetite 5 8 Vomiting 6 12 Diarrhea 6 7 Blood in feces 1 2 Dehydration 0 1 Flatulence 1 0 Increased Borborygmi 1 0 |
| Flatulence | 1/157 | 0/163 | CONVENIA n = 157 Cefadroxil n = 163 Lethargy 2 7 Anorexia/Decreased Appetite 5 8 Vomiting 6 12 Diarrhea 6 7 Blood in feces 1 2 Dehydration 0 1 Flatulence 1 0 Increased Borborygmi 1 0 |
Extraction notes: This single FOI summary covers BOTH species: Section I General Information (Species/Class: 'cats') and Section IV General Information (Species/Class: 'Canine'); the parsed metadata lists cats, so species_class records both verbatim strings. Indication, dose, PK (except the cat half-life row), TAS, effectiveness and adverse-reaction fields are taken from the DOG portion (Sections IV-VI). Effectiveness result sentence (dogs): 'Twenty-eight days after initiation of the final 14-day treatment, each clinical sign of skin infection had been reduced to mild (improved) or absent (cured) in 109 (92.4 %) of CONVENIA-treated dogs and in 108 (92.3%) of cefadroxil-treated dogs.' Adverse-reaction quote is the flattened Table 19 (columns: CONVENIA n=157, cefadroxil n=163). Dog PPK: >98% of dogs predicted to have free cefovecin >= 0.06 µg/mL for 14 days and 82-84% >= 0.25 µg/mL at 7 days after 8 mg/kg SC. CAT portion (not extracted into fields): field study of 291 cats (147 CONVENIA vs 144 cefadroxil 10 mg/lb once daily 14 days), success 86/89 (96.6%) vs 80/88 (90.9%) at Day 28, non-inferior; cat AR table: vomiting 10 vs 14, diarrhea 7 vs 26, anorexia 6 vs 6, lethargy 6 vs 6; cat margin-of-safety study 32 cats at 12/36/60 mg/kg (1.5X/4.5X/7.5X) every 7 days x5, no toxicity, increased vomiting/diarrhea at 36 and 60 mg/kg; cat protein binding 99.5% to 99.8%; cat radiolabel terminal half-life 13 days. Dog tolerance study used single SC 180 mg/kg in 12 Beagles (6 treated, 6 saline).
Cefovecin Sodium for Injection NADA 200-812, Original approval, June 24, 2025; sponsor Qilu Animal Health Products Co., Ltd.; species: Dogs and cats; foi_id 17145; FDA PDF
Indication
Dogs: treatment of skin infections (secondary superficial pyoderma, abscesses, wounds) caused by susceptible Staphylococcus intermedius and Streptococcus canis (Group G). Cats: skin infections (wounds and abscesses) caused by susceptible Pasteurella multocida.
Dose regimen
3.6 mg/lb (8 mg/kg), Subcutaneous injection, single injection; second injection may be given if response incomplete (maximum 2 injections in dogs); cats single one-time injection, therapeutic concentrations maintained 7 days for S. intermedius and 14 days for S. canis (Group G); cats approximately 7 days for P. multocida
Dogs: Administered as a single subcutaneous injection of 3.6 mg/lb (8 mg/kg) body weight. A second subcutaneous injection of 3.6 mg/lb (8 mg/kg) may be administered if response to therapy is not complete.
Extraction notes: Generic (ANADA) lyophilized powder for injection approved on a biowaiver only: 'Based on the formulation characteristics of the generic product, Qilu Animal Health Products Co., Ltd., was granted a biowaiver for the generic product Cefovecin Sodium for Injection (cefovecin sodium).' RLNAD is convenia (NADA 141-285, Zoetis). Summary contains no PK, target animal safety, effectiveness or adverse reaction data (validator warning expected).
Reproduce: foi_structured_search(query="Cefovecin sodium") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).