Sunday, October 19, 2008

POZEN Confirms ANDA Filing for Treximet Tablets

Oct 17, 2008 - POZEN Inc. (NASDAQ: POZN), today announced that POZEN and GlaxoSmithKline (GSK), the holder of the New Drug Application for Treximet, received a letter from Par Pharmaceutical, Inc. (Par) notifying POZEN and GSK that Par submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market sumatriptan 85 mg/naproxen sodium 500 mg tablets, a generic version of the drug sold by GSK under the trade name, Treximet. Par's letter advised POZEN and GSK that it intended to market a generic version of Treximet tablets before the expiration of U.S. Patent Nos. 6,060,499, 6,586,458 and 7,332,183.

The details can be read here.

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