TherapeuticsMD Receives U.S. Food and Drug Administration (FDA) Approval for Supplemental New Drug Application (sNDA) for ANNOVERA®
20 May 2022
Drug Review
BOCA RATON, Fla.--(BUSINESS WIRE)-- TherapeuticsMD, Inc. (NASDAQ:TXMD) (“TXMD” or the “Company”), an innovative, leading women’s healthcare company, today announced the FDA’s approval of a supplemental New Drug Application (sNDA) for ANNOVERA. The sNDA included minor revisions to ANNOVERA’s in vitro release testing specification that allowed for normal manufacturing variability.
With the approval of the sNDA, the Company believes approximately 7,000 additional rings will be able to enter our supply chain and will be available to customers in the second and third quarters of 2022. Today's sNDA approval will enable TherapeuticsMD to better meet short- and long-term customer demand.
“Today’s approval is an important milestone as it will allow us to more efficiently scale, manufacture, and consistently supply ANNOVERA to meet the increasing demand by women who want procedure-free, long-lasting reversible birth control,” said Hugh O’Dowd, Chief Executive Officer of TherapeuticsMD.
ANNOVERA was approved by the FDA in August 2018 as the only long-lasting, reversible, procedure-free birth control.
Please see the Full Prescribing Information, including indication and Boxed WARNING, for ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) at www.annovera.com/pi.pdf.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.
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