GERMAN REGULATORY AUTHORITY COMPLETES INSPECTION OF ATRIX.Atrix Laboratories, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ATRX ATRX Alpha-Thalassemia/Mental Retardation Syndrome, Nondeletion Type, X-Linked ), 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 leu·pro·lide acetate n. A synthetic polypeptide analog of naturally occurring gonadotropin-releasing hormone used in the treatment of advanced prostate cancer. for injectible suspension) prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. products in Germany and the European community. In December 2001, Atrix's European marketing partner, MediGene AG, submitted a Marketing Authorization Application (MAA MAA abbr. macroaggregated albumin ) 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 GMP (guanosine monophosphate): see guanine. )." 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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