TXMD - TherapeuticsMD says FDA rejected production updates for birth control ring

TherapeuticsMD (NASDAQ:TXMD) announced that the FDA had not approved the revisions sought by the company to certain manufacturing specifications related to ANNOVERA, a ring-shaped contraceptive marketed by the company for women. In a Supplemental New Drug Application ((sNDA)), TherapeuticsMD (TXMD) had asked approval for minor updates to the in vitro release testing specification for ANNOVERA. In response, the regulator has issued recommendations and asked for additional data that could lead to approval. Anticipating a potential rise in demand, the company had proposed amendments to manufacturing standards to increase supplies of ANNOVERA. “The Company will continue to manufacture and supply ANNOVERA under the existing specification and will work with the FDA to address their comments,” Hugh O’Dowd, President of TherapeuticsMD (TXMD), remarked. In 2020, revenue from ANNOVERA more than trebled to $19.6M, and in Q3 2021, net product revenue from ANNOVERA rose by ~83.9% to $11.8M.

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TherapeuticsMD says FDA rejected production updates for birth control ring