April 11, 2018 / 10:35 AM / 10 days ago

BRIEF-TherapeuticsMD Enters Into Negotiations With U.S. FDA For TX-004HR

April 11 (Reuters) - TherapeuticsMD Inc:

* ENTERS INTO LABEL NEGOTIATIONS FOR TX-004HR

* ENTERED INTO NEGOTIATIONS WITH U.S. FOOD AND DRUG ADMINISTRATION REGARDING PROPOSED LABEL FOR TX-004HR

* DOES NOT ANTICIPATE PROVIDING SUBSEQUENT UPDATES WITH RESPECT TO LABEL NEGOTIATIONS PRIOR TO PDUFA TARGET ACTION DATE

* PDUFA TARGET ACTION DATE FOR COMPLETION OF FDA’S REVIEW OF NEW DRUG APPLICATION (NDA) FOR TX-004HR IS MAY 29, 2018 Source text for Eikon: Further company coverage: (Reuters.Briefs@thomsonreuters.com)

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