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Mylan receives FDA approval for generic version of Imitrex

8/10/2009

PITTSBURGH A major generic drug maker announced that it has received FDA approval for its version of a popular migraine drug.

Mylan has received approval from the Food and Drug Administration for sumatriptan succinate tablets in 25-, 50- and 100-mg strengths. The drug is a generic version of GlaxoSmithKline's Imitrex.

Currently, Mylan has 120 ANDAs pending FDA approval representing $85.6 billion in annual brand sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $17.3 billion in annual brand sales, according to IMS Health.

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