Doxapram Hydrochloride: what the FDA reviewed for dog products

Respiram™ NADA 200-435, Original approval, November 21, 2006; sponsor Modern Veterinary Therapeutics, LLC; species: Dogs, cats and horses; foi_id 1160; FDA PDF

Indication

Dogs, cats and horses: to stimulate respiration during and after general anesthesia and to speed awakening and return of reflexes after anesthesia; neonate dogs and cats: to initiate/stimulate respiration following cesarean section or dystocia.

Dose regimen

Dogs and cats 2.5 mg/lb IV; horses 0.25 mg/lb IV; neonate puppies 1-5 mg; neonate kittens 1-2 mg, intravenous (adults); subcutaneous, sublingual or umbilical vein (neonates), single administration

Recommended Dosage: Dogs and cats: 2.5 mg/lb intravenous Horses: 0.25 mg/lb intravenous Neonate puppies: 1-5 mg subcutaneous, sublingual or umbilical vein Neonate kittens: 1-2 mg subcutaneous or sublingual

Effectiveness

Waiver from in vivo bioequivalence study (generic of DOPRAM-V, NADA 034-879); no new safety or effectiveness data; result: Biowaiver granted based on formulation characteristics (sterile solution, same active ingredient, concentration and dosage form as the pioneer)

Based on the formulation characteristics of the generic product, Modern Veterinary Therapeutics, LLC was granted a waiver from the requirement of an in vivo bioequivalence study for the generic product RESPIRAM (doxapram hydrochloride solution).

Extraction notes: Generic (ANADA) approval, 2006, sponsor Modern Veterinary Therapeutics, LLC; 20 mg/mL doxapram hydrochloride. Summary covers dogs, cats and horses (a multi-species label, not a dog-only summary). No PK, target animal safety or effectiveness studies are contained in the summary; the biowaiver statement is recorded under effectiveness.