BioCentury
ARTICLE | Clinical News

Vitaros alprostadil regulatory update

October 14, 2013 7:00 AM UTC

Apricus said the German Federal Institute for Drugs and Medical Devices (BfArM) approved Vitaros alprostadil to treat erectile dysfunction (ED). Vitaros now has national approvals in 5 European countries, including Ireland, the Netherlands, Sweden and the U.K. Vitaros was approved under the Europe's decentralized procedure in June, with the Netherlands acting as the reference state. France, Germany, Italy, the U.K., Ireland, Spain, Sweden, Belgium and Luxembourg were concerned member states. Apricus said it is on track to receive the remainder of the approvals through 1Q14. This quarter, Apricus said it is on track to complete its partnering process for Vitaros for the remaining unpartnered territories in Europe, Latin America and North Africa. ...