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Pharmaceuticals / Submissions and Approvals

FDA Warning Letter to Pfizer Could Delay Approval of Copaxone Generic

March 1, 2017
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Momenta Pharmaceuticals revealed that the FDA issued a warning letter to one of Pfizer’s manufacturer facilities contracted to produce the generic version of Teva’s multiple sclerosis drug Copaxone.

The generic drug’s approval hinges on whether Pfizer resolves the compliance issues cited in the warning letter, Momenta said. Glatopa, the Copaxone generic under development by Momenta and Sandoz, is still being reviewed by the FDA and its launch could be delayed by the warning letter.

Momenta said it does not expect the FDA will approve the generic in first quarter of this year. The FDA has not published the warning letter.

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