Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Tuesday, April 28, 2020
FDA Approves First Generic Detomidine Hydrochloride Injectable Solution for Horses
The FDA’s Center for Veterinary Medicine has approved the first generic detomidine hydrochloride injectable solution for horses. Generic detomidine hydrochloride is indicated for use as a sedative and analgesic (pain reliever) to facilitate minor surgical and diagnostic procedures in mature horses and yearlings (adolescent horses) and is an important tool in enabling these animals to receive treatment while managing pain during minor surgical procedures, such as repairing skin lacerations.
The sponsor of an abbreviated new animal drug application (ANADA) for a generic animal drug is required to show that the generic product is bioequivalent to the reference listed new animal drug (in this case, Dormosedan), which has been shown to be safe and effective. Bioequivalence means that the bioavailability of a generic new animal drug and the referenced listed new animal drug (RLNAD) must be the same, meaning that the extent and rate of absorption of the active pharmaceutical ingredient(s) (API) or its metabolite(s) are equal, therefore behaving and acting in the same manner as Dormosedan. The generic drug product is an injectable solution, contains the same active ingredient in the same concentration and dosage form as the RLNAD, and contains no inactive ingredients that may significantly affect the bioavailability of the active ingredient.