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Androxal FDA 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.

In December 2015, Repros Therapeutics Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application for enclomiphene. The FDA stated that, based on recent scientific developments, the design of enclomiphene Phase 3 studies was no longer adequate to demonstrate clinical benefit and recommended that Repros conduct an additional Phase 3 study or studies to support approval in the target population. The FDA also noted concerns regarding study entry criteria, titration and bioanalytical method validation in the Phase 3 program.

Development timeline for Androxal

Dec  1, 2015Repros Therapeutics Receives Complete Response Letter From FDA for Enclomiphene
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

Further information

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