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Auxilium Pharmaceuticals, Inc. Announces Court Grants Upsher-Smith Laboratories Motion For Summary Judgment
Date:12/4/2013

nt. USL's NDA was granted tentative approval by the U.S. Food and Drug Administration ("FDA") on August 16, 2013 with a brand name Vogelxo™. With the granting of USL's summary judgment motion, the FDA may now make the approval final, at which time USL will be permitted to launch its testosterone gel product, whether or not such final approval is accompanied by a therapeutic equivalence rating.

On March 26, 2013, Auxilium submitted a Citizen Petition to the FDA with respect to USL's NDA referencing Testim in particular, and generic testosterone gels in general. The Company requested that, in the event of FDA approval of USL's NDA, the FDA refrain from designating USL's testosterone gel as therapeutically equivalent to Testim, and require that the label state that the product is not interchangeable with other transdermal testosterone gels. Although the FDA has not yet substantively replied to this Citizen Petition, the FDA did communicate to Auxilium that it has not yet resolved the issues raised in the Citizen Petition. The therapeutic equivalence rating may determine whether the product, if launched, would be launched as a generic, a branded generic, or simply another branded competitor in the TRT gel market. It is unclear at this time when the FDA will substantively respond to Auxilium's Citizen Petition. Auxilium is exploring all options to respond to the threat posed to Testim and Auxilium's revenue by any launch of USL's testosterone gel product, whatever the therapeutic equivalence rating. The effect of any such product is not yet known.

About AuxiliumAuxilium Pharmaceuticals, Inc. is a fully integrated specialty biopharmaceutical company with a focus on developing and commercializing products to predominantly specialist audiences. Auxilium markets Testim (testosterone gel) for the topical treatment of hypogonadism in the U.S. and XIAFLEX for the treatment of adult Dupuytren's contracture patients with a palpable cord in the U.S. Ferring Int
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