Dexamethasone, Neomycin Sulfate, Thiabendazole: what the FDA reviewed for dog products

Thiabendazole, Dexamethasone, Neomycin Sulfate Solution NADA 200-565, Original approval, July 15, 2015; sponsor Dechra Veterinary Products LLC; species: Dogs and cats; foi_id 1245; FDA PDF

Indication

Aid in the treatment of certain bacterial, mycotic, and inflammatory dermatoses and otitis externa in dogs and cats.

Dose regimen

Five to 15 drops per ear; 2 to 4 drops per square inch for dermatoses elsewhere, Topical (ear canal or skin lesions), twice daily, Remove ceruminous/purulent/foreign material and crusts before application; amount and frequency depend on severity and extent of lesions

Five to 15 drops should be instilled in the ear twice daily. In treating dermatoses affecting other than the ear the surface of the lesions should be well moistened (2 to 4 drops per square inch) with the solution twice daily.

Effectiveness

No study: bioequivalence waiver granted on formulation characteristics (topical solution, same actives/concentration/dosage form as RLNAD TRESADERM, NADA 042-633); result: Waiver granted; CVM did not require effectiveness or target animal safety studies

Based on the formulation characteristics of the generic product, Putney, Inc. was granted a waiver from the requirement to demonstrate bioequivalence for the generic product Thiabendazole, Dexamethasone, Neomycin Sulfate Solution.

Extraction notes: Generic (ANADA) approval. 'CVM did not require effectiveness studies for this approval.' 'CVM did not require target animal safety studies for this approval.' The single 'PK sentence' flagged in the batch plan is the waiver language about bioavailability, not a PK result.