BioCentury
ARTICLE | Clinical News

Flutiform fluticasone/formoterol regulatory update

July 23, 2012 7:00 AM UTC

SkyePharma said the German Federal Institute for Drugs and Medical Devices (BfArM) approved flutiform fluticasone/formoterol to treat asthma. SkyePharma said partner Mundipharma plans to launch the product this year in Germany, which will trigger a €4 million ($4.9 million) milestone payment to SkyePharma. Earlier this month, the European Commission approved an MAA for flutiform under the decentralized procedure. According to SkyePharma, the 21 member states are required to grant marketing approval. The product is already approved in Cyprus. ...