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Vimovo FDA Approval History

FDA Approved: Yes (First approved April 30, 2010)
Brand name: Vimovo
Generic name: naproxen and esomeprazole magnesium
Previous Name: PN 400
Companies: AstraZeneca, Pozen Inc.
Treatment for: Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, NSAID-Induced Ulcer Prophylaxis

Vimovo is a combination of the pain reliever naproxen (NSAID) and esomeprazole magnesium (proton pump inhibitor) indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

Development timeline for Vimovo

May  3, 2010Approval FDA Approved Vimovo for Arthritis Patients At Risk of Developing NSAID-Associated Gastric Ulcers
Sep  1, 2009Pozen Announces FDA Acceptance of NDA For Vimovo
Jun 30, 2009Pozen Submits New Drug Application For Vimovo (PN 400)
May 13, 2009Pozen Receives Decision from AstraZeneca to File PN 400 NDA

Further information

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