Pozen submits new drug application for Vimovo (PN 400).

Pozen Inc announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the marketing approval of Vimovo (PN 400), the combination of enteric coated (EC) naproxen and immediate release esomeprazole. Pozen and AstraZeneca entered into a global co-development agreement for Vimovo in Aug 2006. Pending regulatory approval, the proposed trade name is Vimovo and the proposed indications are for the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk for developing NSAID-associated ulcers. The NDA submission is based on data from a comprehensive clinical trials programme. Pozen conducted …