First Generic Version of MS Drug Copaxone Approved

After months of anticipation, the FDA has approved a generic version of Copaxone, a widely used multiple sclerosis drug sold by Teva Pharmaceuticals. The move means that Momenta Pharmaceuticals and the Sandoz unit of Novartis, which have a manufacturing and marketing partnership, can now sell a knockoff of a drug that generated more than $3.1 billion in sales in the US last year.

The approval comes after a protracted effort by Teva to convince the FDA not to endorse a generic version. Over the last few years, Teva filed several so-called citizen’s petitions with the agency and argued that formulating a knockoff would be complicated. “It’s a very complex product and not easy to duplicate,” says Craig Wheeler, the Momenta executive. “But we view this as an endorsement of our technology.”

Read more at Wall Street Journal's Pharmalot blog: http://on.wsj.com/1DT9m5t