Seeking Alpha

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)
From other sites
Comments (0)
Be the first to comment
DJIA (DIA) S&P 500 (SPY)
ETF Hub
ETF Screener: Search and filter by asset class, strategy, theme, performance, yield, and much more
ETF Performance: View ETF performance across key asset classes and investing themes
ETF Investing Guide: Learn how to build and manage a well-diversified, low cost ETF portfolio
ETF Selector: An explanation of how to select and use ETFs