FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Releases 25 Product-Specific Guidances for Generics

Oct. 17, 2018

The FDA issued two new and 23 revised product-specific guidances on the development of transdermal and topical delivery system (TDS) generic drugs.

The revised guidances include buprenorphine, clonidine, diclofenac, granisetron and lidocaine, among others. The two newly added guidances cover capsaicin and estradiol; norethindrone acetate.

“In too many cases, there is no generic competition for these costly branded drugs even after they have lost their exclusivity protections,” said FDA Commissioner Scott Gottlieb.

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