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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 under development for the treatment of men of reproductive age with low testosterone levels who want to improve or maintain their fertility and/or sperm function while being treated for low testosterone.

FDA Approval Status for Androxal

DateArticle
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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