With this approval, the Company expects a significant reduction in its manufacturing batch rejections and an increase in future product supply and will enable the Company to better meet short- and long-term customer demand
FDA Building 66 houses the Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration from Wikipedia)
herapeuticsMD, 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.
Source: Company Press Release