Drug delivery company Atrix Laboratories confirmed this week that the German regulatory authority, Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM), had recently completed a successful inspection of Atrix's manufacturing facility.
The move is part of the on-going process of seeking marketing approval for the company's Eligard (leuprolide acetate for injectible suspension) prostate cancer products in Germany and the European community.
In December 2001, Atrix's European marketing partner, MediGene AG, submitted a Marketing Authorisation Application (MAA) for Eligard 7.5mg one-month prostate cancer product. In April 2002, a second MAA was submitted for Eligard 22.5mg three-month prostate cancer product. Both submissions are under review for approval in Germany as a reference member state under a mutual recognition process.
David R. Bethune, chairman and chief executive officer of Atrix commented : "The two BfArM inspectors were here for three and a half days going over the facility. We are pleased to report they found it in compliance with Good Manufacturing Practices (GMP)."