Acepromazine Maleate: what the FDA reviewed for dog products
3 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Acepromazine Maleate, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Canine, Feline and Equine; Dogs; Dogs, cats, and horses.
Products
- Acepromazine Maleate Injection (NADA/ANADA 200-319)
- Acepromazine Maleate Injection (NADA/ANADA 200-361)
- Acepromazine Maleate Tablets (NADA/ANADA 200-757)
Acepromazine Maleate Injection NADA 200-361, Original approval, April 14, 2004; sponsor Boehringer lngelheim Animal Health USA Inc.; species: Dogs, cats, and horses; foi_id 1115; FDA PDF
Indication
Dogs and cats: aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgery; antipruritic; antiemetic for motion sickness; preanesthetic agent. Horses: aid in controlling fractious animals and adjunct to local anesthesia.
Dose regimen
0.25 mg-0.5 mg/lb of body weight (dogs), intravenous, intramuscular or subcutaneous injection, single dose, individualized to the degree of tranquilization required, IV doses given slowly; allow at least 15 minutes for full effect. Cats 0.5-1 mg/lb; horses 2-4 mg/100 lb.
Dogs – 0.25 mg-0.5 mg/lb of body weight Cats – 0.5-1 mg/lb of body weight Horses – 2-4 mg/100 lb of body weight
Extraction notes: Generic (ANADA) approval of a 10 mg/mL injectable (pioneer PROMACE Injectable, NADA 015-030, approved April 8, 1964). No new target animal safety, effectiveness or PK studies: a waiver from an in vivo bioequivalence study was granted because the product is an injection with the same active ingredient, concentration and dosage form and no inactive ingredients affecting absorption. The parsed 'effectiveness' section contains only this waiver text. Validator warning 'no PK, safety or effectiveness content' is expected.
Acepromazine Maleate Tablets NADA 200-757, Original approval, August 31, 2023; sponsor ZyVet Animal Health, Inc.; species: Dogs; foi_id 14444; FDA PDF
Indication
Aid in tranquilization and preanesthetic agent in dogs; aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures.
Dose regimen
0.25 – 1.0 mg/lb of body weight, oral (10 mg and 25 mg tablets), may be repeated as required
0.25 – 1.0 mg/lb of body weight. Dosage may be repeated as required.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 185.0 (ng/mL)*hour (generic tablet, geometric mean) | single oral 25 mg tablet, fasted, n=42 beagles, crossover; 90% CI; AUC from time 0 to last quantifiable concentration. Table columns: Generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI. | AUC (ng/mL)*hour 185.0† 187.7† 0.99 0.89 1.09 |
| auc | 187.7 (ng/mL)*hour (RLNAD PromAce tablet, geometric mean); generic:RLNAD ratio 0.99 (CI 0.89-1.09) | single oral 25 mg tablet, fasted, n=42 beagles, crossover | AUC (ng/mL)*hour 185.0† 187.7† 0.99 0.89 1.09 |
| cmax | 44.6 ng/mL (generic tablet, geometric mean) | single oral 25 mg tablet, fasted, n=42 beagles, crossover; 90% CI. Table columns: Generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI. | CMAX (ng/mL) 44.6† 48.1† 0.93 0.80 1.07 |
| cmax | 48.1 ng/mL (RLNAD PromAce tablet, geometric mean); generic:RLNAD ratio 0.93 (CI 0.80-1.07) | single oral 25 mg tablet, fasted, n=42 beagles, crossover | CMAX (ng/mL) 44.6† 48.1† 0.93 0.80 1.07 |
| tmax | 1.35 hours (generic tablet, arithmetic mean, SD 0.65) | single oral 25 mg tablet, fasted, n=42 beagles; TMAX summarized only, not statistically evaluated (NE = not estimated) | TMAX (hours) (SD)‡ 1.35 (0.65)‡ 1.14 (0.46)‡ NE NE NE |
| tmax | 1.14 hours (RLNAD PromAce tablet, arithmetic mean, SD 0.46) | single oral 25 mg tablet, fasted, n=42 beagles; TMAX summarized only, not statistically evaluated | TMAX (hours) (SD)‡ 1.35 (0.65)‡ 1.14 (0.46)‡ NE NE NE |
Effectiveness
BIOEQUIVALENCE STUDY (not an effectiveness study): masked, randomized, two-period, two-sequence, single oral dose crossover blood-level study of generic 25 mg acepromazine maleate tablets vs RLNAD PromAce 25 mg tablets in healthy fasted male beagles, 7-day washout (Study 113-BC-2321, GLP).; n = 42; primary endpoint: CMAX and AUC; bioequivalence if 90% CI of the generic:RLNAD geometric mean ratio lies within 0.80-1.25; result: Bioequivalence demonstrated: AUC ratio 0.99 (90% CI 0.89-1.09), CMAX ratio 0.93 (90% CI 0.80-1.07). A biowaiver for the 10 mg tablet was granted on the basis of comparative in vitro dissolution (>85% in 15 minutes for all comparisons).
The in vivo blood-level study was conducted in 42 healthy, fasted dogs.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| No serious adverse events (bioequivalence study) | No serious adverse events were reported during the study. |
Extraction notes: Generic (ANADA) approval; RLNAD is PromAce Tablets (NADA 117-532). No target animal safety or clinical effectiveness studies; the 'effectiveness' entry records the pivotal blood-level bioequivalence study. PK values are from Table II.1 (columns: Generic mean, RLNAD mean, Ratio, lower 90% CI, upper 90% CI; † geometric mean, ‡ arithmetic mean and SD). Study animals: 42 male beagles (41 intact, 1 neutered), 9.3-12.6 kg.
Acepromazine Maleate Injection NADA 200-319, Original approval, March 25, 2003; sponsor Elanco US Inc.; species: Canine, Feline and Equine; foi_id 1069; FDA PDF
Indication
Dogs and cats: aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgery; antipruritic; antiemetic for motion sickness; preanesthetic agent. Horses: aid in controlling fractious animals and adjunct to local anesthesia.
Dose regimen
0.25-0.5 mg/lb of body weight (dogs), intravenous, intramuscular or subcutaneous injection, single dose, individualized to the degree of tranquilization required, IV doses given slowly; allow at least 15 minutes for full effect. Cats 0.5-1 mg/lb; horses 2-4 mg/100 lb.
Dogs: 0.25-0.5 mg/lb of body weight Cats: 0.5-1 mg/lb of body weight Horses: 2-4 mg/100lb of body weight
Extraction notes: Generic (ANADA) approval of a 10 mg/mL injectable (pioneer PromAce Injectable, NADA 015-030). No new target animal safety, effectiveness or PK studies: the sponsor was granted a waiver from an in vivo bioequivalence study on October 20, 1997 because the generic and pioneer products contain the same active and inactive ingredients in the same concentrations. Validator warning 'no PK, safety or effectiveness content' is expected. The 'x- ray' spacing in the indication quote reproduces a line-break artefact in the extracted text.
Reproduce: foi_structured_search(query="Acepromazine Maleate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).