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Momenta Pharmaceuticals Inc. Message Board

  • erp3359 erp3359 Jul 10, 2014 6:22 PM Flag

    TEVA tactics are frivolous no impact on copaxone approval FDA does not

    While it must respond within 180 days, the FDA does not have to respond to a citizen petition before it rules on a related ANDA. 7 The FDA’s policy is to assess a citizen petition prior to approving a related ANDA, but the agency does not always issue its formal response to the petition before ruling on the ANDA.

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