Research & Development
TherapeuticsMD Receives US Food and Drug Administration Approval for Supplemental New Drug Application for Annovera
20 May 2022 - - The US FDA has approved of a supplemental New Drug Application for Annovera, US-based TherapeuticsMD, Inc. (NASDAQ: TXMD) said.


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.

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

TherapeuticsMD, Inc. is a healthcare company focused on developing and commercializing novel products exclusively for women.
Login
Username:

Password:


Related Headlines