Nixed by the FDA, TherapeuticsMD is now planning a long-shot bid to reverse the decision
TherapeuticsMD already flagged that the FDA was about to reject its application for TX-004HR, a proposed new therapy to treat vaginal pain during intercourse for women with vulvar and vaginal atrophy triggered by menopause. Today it confirmed that the agency has indeed nixed the treatment, and it’s preparing a rebuttal case to see if they can turn it around.
That’s doubtful, as the FDA rarely reverses course once regulators have made up their minds — though it can happen.
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