FDA delays decision on Auxilium's Xiaflex drug

The FDA has extended its deadline by three months to December 6 for deciding whether or not to approve Auxilium Pharmaceuticals' (AUXL) Xiaflex drug for treating Peyronie's disease, which can result in penile curvature deformity, sexual dysfunction and emotional distress.

Auxilium is continuing to prepare for the commercialization of Xiaflex on the assumption that it will receive authorization by the new date.

The FDA delayed its decision after Auxilium submitted revisions to its proposed risk evaluation and mitigation strategy, as well as to other elements of its approval request. (PR)

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