FDA BRIEF: Week of April 11, 2016


  • 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



  • 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


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s