FDA Releases 43 New Product-Specific BE Guidances
The FDA has published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs.
The documents cover 43 drug products, including some that are still protected from generic competition — among them, Sovaldi (sofosbuvir) and Olysio (simeprevir) for hepatitis C, Jardiance (empagliflozin) for type 2 diabetes, Northera (droxidopa) for hypotension and Xtandi (enzalutamide) for metastatic prostate cancer.
Sofosbuvir also is an active ingredient, along with ledipasvir, in the hepatitis C drug Harvoni. Both drugs are made by Gilead Sciences and have come under intense criticism for their cost.
The list also includes such long-time treatments as aspirin and nitroglycerin.
In addition to the new guidance documents, the FDA issued revised drafts for three therapies: antibiotic Doryx (doxycycline hyclate), platelet inhibitor Effient (prasugrel hydrochloride) and anticonvulsive Gabitril (tiagabine hydrochloride).
The agency issues product-specific BE recommendations periodically.