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