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ARTICLE | Clinical News

TherapeuticsMD receives CRL for Yuvvexy

May 11, 2017 10:22 PM UTC

TherapeuticsMD Inc. (NYSE-M:TXMD) said FDA issued a complete response letter to an NDA for Yuvvexy (TX-004HR) to treat moderate to severe vaginal pain during sexual intercourse associated with vulvar vaginal atrophy due to menopause. The company said the letter cited a lack of long-term endometrial safety data beyond the 12 weeks studied in the Phase III Rejoice trial...

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