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Repros announces acceptance for NDA acceptance by FDA

By Religare

Repros Therapeutics, a development stage biopharmaceutical company headquartered in The Woodlands, Texas, announced that the New Drug Application (NDA) for its enclomiphene citrate product candidate, formerly known as Androxal, has been accepted by the U.S. Food and Drug Administration (FDA), indicating that the application is sufficiently complete to permit a substantive review.

This investigational product, which is the Company's lead product candidate, is a single isomer of clomiphene citrate and an orally active proprietary small molecule compound.


Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.

Story first published: Thursday, April 2, 2015, 12:40 [IST]
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