Benzinga | Dec 10, 2021 04:32PM EST

TherapeuticsMD Reports FDA 'determined that it could not approve proposed revisions to the manufacturing testing limits requested through the Supplemental New Drug Application'

- FDA determined that it could not approve proposed revisions to the manufacturing testing limits requested through the Supplemental New Drug Application (sNDA) -

- FDA provided recommendations and requested additional information to address the issues -

- The Company will continue to supply ANNOVERA in compliance with the manufacturing testing limits approved in the original NDA -

BOCA RATON, Fla.--(BUSINESS WIRE)-- TherapeuticsMD, Inc. (NASDAQ:TXMD) ("TXMD" or the "Company"), an innovative, leading women's healthcare company, today announced that the FDA determined that it could not approve revisions to certain manufacturing testing limits for ANNOVERA through the sNDA previously submitted by the Company. In its complete response letter, the FDA provided recommendations and requested additional information that could support approval of revisions to certain manufacturing testing limits. The Company will continue to manufacture and supply ANNOVERA under the existing approved specifications.

The sNDA requested minor revisions to the in vitro release testing specification for ANNOVERA to allow for normal commercial manufacturing variation. The Company submitted the proposed revisions to the manufacturing testing limits to allow it to efficiently and quickly increase supply to meet anticipated patient demand for ANNOVERA.

"The Company will continue to manufacture and supply ANNOVERA under the existing specification and will work with the FDA to address their comments," said Hugh O'Dowd, President of TherapeuticsMD.

ANNOVERA was approved by the FDA in August 2018 as the only long-lasting, reversible, procedure-free birth control.