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. ...