Auxilium (AUXL) Says Watson (WPI) Files ANDA with Paragraph IV for Testosterone Gel

Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) and FCB I LLC ("FCB") today announced that they have received a notice from Watson Laboratories, Inc. (NYSE: WPI) 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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