BioCentury
ARTICLE | Clinical News

Duexis ibuprofen/famotidine regulatory update

January 7, 2013 8:00 AM UTC

On Dec. 21, 2012, Horizon said the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) recommended approval of Duexis ibuprofen/famotidine to treat osteoarthritis (OA), rheumatoid arthritis and ankylosing spondylitis and to reduce the risk of developing upper gastrointestinal ulcers. The MAA for Duexis is being reviewed under the EU Mutual Recognition Procedure, with the U.K. acting as the reference member state. Horizon said it plans to seek a commercialization partner for Duexis in the EU. ...