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POZEN IND and NDA for Treximet™ (Sumatriptan/Naproxen Sodium) Transferred to GlaxoSmithKline
Posted: 05-14-2008 : CHAPEL HILL, N.C.
CHAPEL HILL, N.C. -- POZEN Inc. (NASDAQ: POZN), announced today that the U.S. Food and Drug Administration has been notified that ownership of the IND (Investigational New Drug application) and NDA (New Drug Application) for Treximet has been officially transferred to GlaxoSmithKline.
The FDA approved Treximet for the acute treatment of migraine attacks, with or without aura, in adults on April 15, 2008. Treximet will be commercialized by GlaxoSmithKline.
About POZEN
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. POZEN’s efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has development and commercialization alliances with GlaxoSmithKline for Treximet™, which was recently approved by the United States Food and Drug Administration for the acute treatment of migraine attacks, and with AstraZeneca for proprietary fixed dose combinations of naproxen with the proton pump inhibitor esomeprazole magnesium in a single tablet for conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers. The company’s common stock is traded on The Nasdaq Stock Market under the symbol “POZN”. For detailed company information, including copies of this and other press releases, see POZEN’s website: www.pozen.com.
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