BioCentury
ARTICLE | Clinical News

Vitaros alprostadil regulatory update

December 9, 2013 8:00 AM UTC

Apricus said the Italian Medicines Agency (AIFA) approved Vitaros alprostadil to treat erectile dysfunction (ED). Vitaros was approved under the Europe's decentralized procedure in June, with the Netherlands acting as the reference state. Concerned member states Germany, Ireland, Italy, the Netherlands, Sweden and the U.K. have approved the drug, which is still under review in France, Spain, Belgium and Luxembourg. Apricus said it is on track to receive the remainder of the approvals through 1Q14 and expects its partners to launch the product throughout 2014. Apricus expects to close partnering negotiations this quarter for Vitaros for the remaining unpartnered territories in Europe, Latin America and parts of Africa. ...