FDA Publishes 57 Product-Specific Guidances for Generics

The FDA issued 35 new draft and 22 revised product-specific guidances for generic drugs, including the pain treatment buprenorphine, the skin disorder treatment fluocinonide and the multiple myeloma drug ixazomib citrate.

“To date, we’ve now published about 1,600 of these product-specific guidances laying out the path for developing generics to specific products; including more than 350 guidances for developing generics of complex drugs,” said FDA Commissioner Scott Gottlieb.

Brand-name drugs referenced by generics covered by the new guidance include Teva’s fungal infection treatment ketoconazole, Novartis’ ADHD treatment Ritalin-SR (methylphenidate HCl) and Bayer’s Aleve-D Sinus & Cold (naproxen and pseudoephedrine).

The revised guidances include the cystine reducer cysteamine bitartrate, the hepatitis C treatment daclatasvir dihydrochloride, the anticonvulsant felbamate, proton pump inhibitors lansoprazole and dexlansoprazole, and the pain treatment oxycodone.