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The FDA has published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs.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.

Read the notice on the new and revised drafts here: www.fdanews.com/6-15-FDA-BE-Notice.pdf. The individual guidances are at www.fdanews.com/6-15-FDA-BE-Guidances.pdf. — Jonathon Shacat