BioCentury
ARTICLE | Clinical News

Vitaros alprostadil regulatory update

January 6, 2014 8:00 AM UTC

On Dec. 19, 2013, Apricus said France's National Agency for Medicines and Health Products Safety (ANSM) approved Vitaros alprostadil to treat erectile dysfunction (ED). Vitaros was approved under Europe's decentralized procedure in June, with the Netherlands acting as the reference state. Concerned member states Germany, Ireland, Italy, Sweden and the U.K. have approved the drug, which is still under review in Spain, Belgium and Luxembourg. Apricus expects its partners to launch the product throughout 2014. In November, Apricus granted Laboratoires Majorelle (Paris, France) exclusive rights to market Vitaros in France, Monaco and certain African countries (see BioCentury, Nov. 25, 2013). ...