Pentobarbital Sodium, Phenytoin Sodium: what the FDA reviewed for dog products
3 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Pentobarbital Sodium, Phenytoin Sodium, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Canine; Dogs.
Products
- Euthanasia-III Solution (NADA/ANADA 200-280)
- Euthasol® (NADA/ANADA 200-071)
- Pentobarbital Sodium and Phenytoin Sodium (NADA/ANADA 200-614)
Euthanasia-III Solution NADA 200-280, Original approval, February 03, 2005; sponsor Dechra Veterinary Products LLC; species: Dogs; foi_id 1034; FDA PDF
Indication
Humane, painless and rapid euthanasia of dogs.
Dose regimen
1 mL for each 10 pounds of body weight, intravenous or intracardiac, single administration, 390 mg pentobarbital sodium + 50 mg phenytoin sodium per mL; 100 mL multiple-dose vial
Recommended Dosage: 1 mL for each 10 pounds of body weight.
Extraction notes: Generic (ANADA) approval (2005) of Med-Pharmex's Euthanasia-III Solution referencing BEUTHANASIA-D Special (NADA 119-807). An in vivo bioequivalence waiver was granted on formulation grounds (same actives, concentration and dosage form; no absorption-affecting inactive ingredients). No studies in the summary.
Pentobarbital Sodium and Phenytoin Sodium NADA 200-614, Original approval, February 07, 2020; sponsor Noble Pharma, LLC; species: Dogs; foi_id 8387; FDA PDF
Indication
Humane, painless and rapid euthanasia of dogs.
Dose regimen
1 mL for each 10 pounds of body weight, intravenous (preferred) or intracardiac when intravenous is impractical, single administration, 390 mg/mL pentobarbital sodium and 50 mg/mL phenytoin sodium; 100 mL multi-dose vials
J. Dosage Regimen 1 mL for each 10 pounds of body weight K. Route of Administration Intravenous injection is preferred. Intracardiac injection may be made when intravenous injection is impractical, as in a very small dog or in a comatose dog with impaired vascular functions.
Extraction notes: Generic (ANADA) approval (2020) for Akorn Animal Health referencing BEUTHANASIA-D SPECIAL (NADA 119-807). A biowaiver was granted on formulation grounds; no in vivo studies, PK, safety or effectiveness data in the summary. The single 'PK sentence' flagged by the batch plan is the biowaiver rationale ('contains no inactive ingredients that may significantly affect the bioavailability of the active ingredient').
Euthasol® NADA 200-071, Original approval, February 24, 1994; sponsor Virbac AH, Inc.; species: Canine; foi_id 1341; FDA PDF
Indication
Humane, painless and rapid euthanasia of dogs.
Dose regimen
1 mL for each 10 pounds of weight, intravenous (preferred) or intracardiac when intravenous is impractical, single bolus injection, 390 mg pentobarbital sodium + 50 mg phenytoin sodium per mL
Labeled Dosage M. 1 mL for each 10 pounds of weight.
Extraction notes: Generic (ANADA) approval (1994) referencing Beuthanasia-D Special (NADA 119-807). The summary contains no studies; it recites the GADPTRA framework under which new safety and effectiveness data are not required and a bioequivalence waiver may be granted for certain dosage forms. Species/Class stated as 'Canine'.
Reproduce: foi_structured_search(query="Pentobarbital Sodium, Phenytoin Sodium") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).