Brief: U.S. Food And Drug Administration (FDA) Responds To Request From Therapeuticsmd To Revise Certain Manufacturing Testing Limits For Annovera

TherapeuticsMD

10/12/2021 21:34

Dec 10 (Reuters) - TherapeuticsMD Inc  TXMD.O :
    * U.S. FOOD AND DRUG ADMINISTRATION (FDA) RESPONDS TO
REQUEST FROM
THERAPEUTICSMD TO REVISE CERTAIN MANUFACTURING TESTING LIMITS
FOR ANNOVERA®
    * THERAPEUTICSMD INC - FDA DETERMINED THAT IT COULD NOT
APPROVE
PROPOSED REVISIONS TO MANUFACTURING TESTING LIMITS REQUESTED
THROUGH SNDA
    * THERAPEUTICSMD INC - FDA PROVIDED RECOMMENDATIONS AND
REQUESTED
ADDITIONAL INFORMATION TO ADDRESS ISSUES
    * THERAPEUTICSMD INC - WILL CONTINUE TO SUPPLY ANNOVERA IN
COMPLIANCE WITH MANUFACTURING TESTING LIMITS APPROVED IN
ORIGINAL NDA
    * THERAPEUTICSMD INC - SUBMITTED PROPOSED REVISIONS TO
MANUFACTURING TESTING LIMITS

Source text for Eikon:  ID:nBw7CpRr4a 
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