BioCentury
ARTICLE | Clinical News

Trelstar decapeptyl triptorelin pamoate regulatory update

October 19, 2009 7:00 AM UTC

Debiopharm and Ipsen said an MAA for a 6-month formulation of 22.5 mg Decapeptyl triptorelin pamoate to treat locally advanced or metastatic, hormone-dependent prostate cancer has completed the decentralized procedure, with Germany acting as the reference member state. The company said the product will be approved within 30 days in Austria, Belgium, Denmark, Finland, France, Germany, the Netherlands, Norway and Spain. The controlled-release formulation of triptorelin pamoate, a synthetic GnRH/LHRH receptor agonist, already is approved in 1- and 3-month formulations. ...