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  1. CVM Updates

FDA Approves First Generic Detomidine Hydrochloride Injectable Solution for Horses

April 28, 2020

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.

Licensed veterinarians administering detomidine hydrochloride should ensure that they don’t inadvertently get the drug in their mouth, as safety studies have indicated that the drug is well absorbed through mucous membranes, such as the lining of the mouth or nose. Exposure of eyes or skin should be avoided and affected areas should be washed immediately if exposure does occur. As with all injectable drugs that cause profound physiological effects, veterinarians should take routine precautions when handling and using loaded syringes to prevent accidental self-injection.

Generic detomidine hydrochloride is available by prescription only and is available in 5 mL and 20 mL multidose vials.

The drug is sponsored by Modern Veterinary Therapeutics, LLC based in Miami, Florida.

For more information:

Freedom of Information Summary

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

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