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FDA Panel Votes for Approval of Hand Tendon Drug

By Pharmaceutical Processing | September 17, 2009

NEW YORK (AP) — An FDA panel is recommending approval of a drug intended to treat an arthritis-like condition of the hands, the drug’s makers said. Late Wednesday, Auxilium Pharmaceuticals Inc. and BioSpecifics Technologies Corp. said an FDA panel voted unanimously to recommended approval of the drug candidate Xiaflex. Xiaflex is being developed as a treatment for Dupuytren’s contracture, a condition related to diabetes that causes the tendons of the hand to shorten, making the fingers curve inward. The FDA is not required to follow the recommendations of its panels, but it often does. Xiaflex was discovered by Lynbrook, N.Y.-based BioSpecifics and licensed to Malvern, Pa.-based Auxilium.

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