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Androxal Approval Status

  • FDA approved: No
  • Brand name: Androxal
  • Generic name: enclomiphene
  • Company: Repros Therapeutics Inc.
  • Treatment for: Hypogonadism, Male

Androxal (enclomiphene) is a non-steroidal estrogen receptor antagonist in development for secondary hypogonadism in overweight men wishing to restore normal testicular function.

Development Status and FDA Approval Process for Androxal

Oct 29, 2015Repros Therapeutics Announces Cancellation of FDA Advisory Committee Meeting to Review Enclomiphene for the Treatment of Secondary Hypogonadism
Jun  8, 2015Repros Announces Date of FDA Advisory Committee Review of NDA
Apr 15, 2015Repros Announces November 30, 2015 PDUFA Goal Date for Enclomiphene Citrate NDA
Feb  2, 2015Repros Submits New Drug Application to FDA for Androxal
Mar 27, 2013Repros Reports Both Primary Endpoints Successfully Met in First Pivotal Study of Androxal
Feb  8, 2010Repros Submits Response to FDA Regarding Androxal Indication for Treatment of Hypogonadal Men Wishing to Preserve Fertility

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