Repros Therapeutics (RPRX) Announces EMA Acceptance of Dossier for Enclomiphene
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Repros Announces Acceptance of Dossier for Enclomiphene for Secondary Hypogonadism by European Authorities
October 5, 2016 10:35 AM EDTTHE WOODLANDS, Texas, Oct. 05, 2016 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq: RPRX) today announced that it has received confirmation of acceptance of its September 12, 2016 filing for enclomiphene in the treatment of secondary hypogonadism in Europe.
Analogous to acceptance of an NDA by U.S. Food and Drug AdministrationResponses expected by end of January 2017The MAA was submitted to the European Medicines Agency (EMA) by Renable Pharma Limited, the UK subsidiary of Repros.Â
As has been described in previous communications, the typical time from submission to... More
