FDA Approves Priority Review for Abarelix Depot NDA for Prostate Cancer
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PRAECIS PHARMACEUTICALS INCORPORATED Announces FDA Priority Review and Filing of its Abarelix Depot NDA for Prostate Cancer
CAMBRIDGE, Mass., Jan. 25 /PRNewswire/ -- PRAECIS PHARMACEUTICALS INCORPORATED (Nasdaq: PRCS - news) today announced that the United States Food and Drug Administration (FDA) has informed the company that the FDA has accepted and filed the Company's New Drug Application (NDA) for abarelix depot for the hormonal treatment of prostate cancer. In addition, the FDA advised the Company that the Agency has granted abarelix depot priority review, a classification applied to a product that, if approved, would in the FDA's judgment represent a significant improvement compared to marketed products. The FDA's classification of this NDA as a priority review means that the Agency is committed to complete its review of the NDA within six months of the submission, which would be June 12, 2001. During the review period, the Agency may ask for additional information that could extend its review beyond June 12, 2001. Following completion of its review, the FDA will inform the Company whether or not the drug is approved for marketing, and if not, what additional steps are necessary for its approval.
PRAECIS PHARMACEUTICALS INCORPORATED is a biotechnology company focused on the discovery and development of pharmaceutical products using its proprietary LEAP(TM) (Ligand Evolution to Active Pharmaceuticals) technology. LEAP combines the power of biological selection with the advantages of medicinal chemistry in a unique molecular evolution process. PRAECIS successfully employed LEAP in the development of abarelix depot, its lead candidate for the treatment of prostate cancer and endometriosis. PRAECIS also has programs in Alzheimer's disease, pain management and AIDS. |
