Atrix Laboratories, Inc. (NASDAQ:ATRX), Fort Collins, Colo., has announced that the German regulatory authority, Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM), has completed a successful inspection of Atrix's manufacturing facility as part of the on-going process of seeking marketing approval for the company's Eligard(R) (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 Authorization 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, Atrix's chairman and chief executive officer 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)."
Atrix Laboratories, Inc. is an emerging specialty pharmaceutical company focused on advanced drug delivery. With five unique patented technologies, Atrix is currently developing a diverse portfolio of proprietary products, including oncology, pain management, and dermatology products. The company also partners with large pharmaceutical and biotechnology companies to apply its proprietary technologies to new chemical entities or improve existing products.
For more information call 970-482-5868 or visit http://www.atrixlabs.com.
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