FDA approves first generic of Teva's MS drug Copaxone

The US Food and Drug Administration yesterday approved the first generic version of Israel-based Teva Pharmaceutical Industries’ (NYSE: TEVA) Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).

The FDA granted marketing approval of Swiss pharma giant Novartis (NOVN: VX) generics subsidiary Sandoz's Abbreviated New Drug Application for once daily Glatopa (glatiramer acetate injection, formerly M356). Glatopa was developed under a collaboration agreement between Momenta Pharmaceuticals (Nasdaq: MNTA) and Sandoz and is the second complex generic developed by Momenta together with Sandoz to receive FDA approval. Glatopa will be commercialized under the Sandoz brand.

FDA reviewed additional information on Glatopa to ensure safety and efficacy