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Pozen to file NSAID/PPI combo

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pozen will file the NDA for the NSAID/PPI combination product PN 400 in mid-2009, the firm announced May 13. With partner AstraZeneca, Pozen developed the fixed-dose combination of the NSAID naproxen with the PPI esomeprazole to treat the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing gastric ulcers (1"The Pink Sheet" DAILY, Aug. 2, 2006). Pozen's announcement suggests that FDA has resolved its concerns about the appropriateness of reduction in gastric ulcers as an endpoint for approval of a gastroprotective claim for NSAID/PPI combos (2"Pharmaceutical Approvals Monthly," December 2008, p. 34)

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