TherapeuticsMD receives CRL for Yuvvexy

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...