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FDA Approved Vimovo for Arthritis Patients At Risk of Developing NSAID-Associated Gastric Ulcers

Posted 3 May 2010 by Drugs.com

WILMINGTON, Del., April 30 /PRNewswire-FirstCall/ – AstraZeneca and Pozen Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Vimovo (naproxen and esomeprazole magnesium) delayed-release tablets 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.(1) Vimovo, co-developed by Pozen Inc. and AstraZeneca, is a fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a proton pump inhibitor (PPI). The FDA approval was supported by data from a clinical development program, including results from the pivotal PN400-301 and PN400-302 studies, which showed patients taking Vimovo experienced significantly ... Read more

Related support groups: Rheumatoid Arthritis, Osteoarthritis, Naproxen, Ankylosing Spondylitis, Esomeprazole, NSAID-Induced Ulcer Prophylaxis

Simponi Approved for Immune-Related Arthritis

Posted 24 Apr 2009 by Drugs.com

FRIDAY, April 24 – Simponi (golimumab) has been approved by the U.S. Food and Drug Administration to treat three forms of arthritis that occur when the body's immune system attacks the joints. The injected drug, administered once a month, was sanctioned to treat moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis, the agency said in a news release. It's among a class of drugs that target tumor necrosis factor-alpha (TNF-α). When overproduced, this protein can cause inflammation and damage to bones, cartilage, and tissue. As with similar medicines, Simponi's label will include a so-called "black-box" warning that users face an increased risk of tuberculosis and invasive fungal infections, the FDA said. Common side effects of the drug include upper respiratory tract infection, sore throat, and nasal congestion. Simponi is marketed by ... Read more

Related support groups: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis

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