FDA Rejects TherapeuticsMD Estrogen Therapy

May 9, 2017

TherapeuticsMD announced that the FDA has rejected the drug developer's application to market its drug to treat vaginal pain.

Florida-based TherapeuticsMD received a Complete Response Letter from the FDA regarding its New Drug Application for TX-004HR, the company’s investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse.

TherapeuticsMD disagrees with the FDA's rejection and will ask for a meeting with the agency within 30 days to clarify exactly what's needed. If the agency sticks with its request, the drugmaker will be forced to conduct an entirely new clinical trial of TX-004HR that lasts at least 12 months.

Read the Reuters article