FDA BRIEF: Week of April 11, 2016

luveris

  • FDA approved LUVERIS in 2004, under the Accelerated Approval regulations
  • Indication: Stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound luteinizing hormone deficiency
  • EMD Serono requested wiithdrawal of  NDA approval as it was not feasible to complete a trial that the company had agreed to at the time of approval

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advicor

  • FDA approved ADVICOR in 2001 and SIMCOR in 2008
  • Indication: Treatment of hypercholesterolemia
  • Collective evidence from several large cardiovascular outcome trials no longer support efficacy conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDLcholesterol levels results in reduction in the risk of cardiovascular events
  • Benefits of ADVICOR and SIMCOR no longer outweigh the risks

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