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Auxilium Pharmaceuticals, Inc. and FCB I LLC Receive Paragraph IV Certification Notice from Watson Laboratories, Inc. for Testim®
Date:4/16/2012

MALVERN, Pa. and MAHWAH, N.J., April 16, 2012 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. and FCB I LLC ("FCB") today announced that they have received a notice from Watson Laboratories, Inc. ("Watson") that advises them of Watson's filing of an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for testosterone gel. This Paragraph IV certification notice refers to FCB's nine U.S. patents, covering Testim®, 1% testosterone gel, that are listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration.  The referenced patents will expire between 2023 and 2025. 

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Auxilium and FCB are currently reviewing the details of this notice from Watson. Auxilium and FCB intend to pursue all available legal and regulatory options in defense of Testim, including enforcement of their intellectual property rights and approved labeling.

About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences. Auxilium markets XIAFLEX® (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord and Testim® 1%, a testosterone gel, for the topical treatment of hypogonadism in the U.S. Pfizer has marketing rights for XIAPEX® (the EU tradename for collagenase clostridium histolyticum) in Europe; Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan; and Actelion Pharmaceuticals Ltd has development and commercial rights for XIAFLEX in Canada, Australia, Brazil and Mexico. Ferring International Center S.A. markets Testim in the
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SOURCE Auxilium Pharmaceuticals, Inc.
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