AstraZeneca has announced that its development partner Pozen, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Vimovo (PN400) (enteric coated naproxen /esomeprazole magnesium) tablets.
It is a product that is under investigation for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in patients who are at risk of developing NonSteroidal Anti-Inflammatory Drug (NSAID)-associated ulcers.
PN400 is a fixed-dose combination of enteric coated naproxen and immediate release esomeprazole. The proposed trade name is Vimovo, pending regulatory approval. Upon the FDA's notification of acceptance of the NDA filing, a US$10 million milestone payment from AstraZeneca will be payable to Pozen.
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