FDA rejects Teva’s petition to block generic Copaxone

A generic version of Teva’s multiple sclerosis treatment could enter the market next year.

Yael Gruntman13 May 10 18:50

The US Food and Drug Administration has rejected a second civil petition by Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) to block approval of a generic version of its Copaxone treatment for multiple sclerosis. Teva submitted its petition last November after its first attempt had failed earlier in 2009.

The FDA denied the second petition for the same reason as the first attempt, because it would be “premature and inappropriate” to grant Teva’s requests, but gave a detailed response that rejects many of the company’s arguments against the generic approval.

Momenta Pharmaceuticals Inc. (NYSE: MNTA) and Mylan Inc. (NYSE: MYL) have both filed to produce generic versions of Copaxone, a process that is likely to span years. The drug, one of the world’s best selling multiple sclerosis treatments and an important part of Teva’s business.

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