FDA Issues 21 New Product-Specific Draft Guidances for Generics, 16 Revised

The FDA published 21 new and 16 revised product-specific draft guidances, outlining methods for establishing bioequivalence for generics.

The new guidances cover several widely used reference drugs, such as nitroglycerin and hydrocortisone cream, as well as amphetamine, clonazepam and nystatin.

The documents describe the FDA’s recommendations for necessary in vivo and in vitro studies for each drug, as well as acceptable waiver requests and the analytes sponsors should measure.

Among the reference drugs with new recommendations are AbbVie’s Venclexta cancer treatment and Gilead’s hepatitis C combination therapy Epclusa — both were approved in 2016, and carry at least four years of FDA exclusivity. Also covered is Jentadueto XR, developed by Boehringer Ingelheim and Eli Lilly, which was approved last year for type 2 diabetes.