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Teva sues FDA over Copaxone Citizen's Petition

May 10, 2014 1:54 AM UTC

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) sued FDA in the U.S. District Court for the District of Columbia alleging that the agency's denial "without comment" of a December Citizen's Petition about multiple sclerosis drug Copaxone glatiramer acetate violates the Food, Drug & Cosmetic Act (FDCA).

The December 2013 Citizen's Petition, Teva's sixth for Copaxone, asked FDA to refrain from approving any ANDA unless it contains information showing the generic contains the identical active ingredient, non-clinical and clinical data showing the generic poses no greater immunogenicity risks, and data from comparative clinical trials in patients with relapsing-remitting MS (RRMS) using relevant safety and effectiveness endpoints to show bioequivalence to Copaxone. ...