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News Breaks | | | | January 3, 2013 | | 07:03 EDT |  | AUXL | Auxilium and Xstelos receive certification notice from Upsher-Smith for Testim
Auxilium and Xstelos announced that they have received a notice from Upsher-Smith Laboratories that advises them of USL's filing of a 505b2 New Drug Application containing a Paragraph IV certification under 21 U.S.C. Section 314.52c for testosterone gel. These ten patents are owned by FCB I LLC, an indirect majority owned subsidiary of Xstelos. Xstelos holds the assets of CPEX Pharmaceuticals, the predecessor owner of the patents. The referenced Testim patents will expire between 2023 and 2025. Auxilium and Xstelos are currently reviewing the details of this notice from Upsher Smith. Auxilium and Xstelos intend to pursue all available legal and regulatory options in defense of Testim, including enforcement of their intellectual property rights and approved labeling. | |
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