The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Annovera® (segesterone acetate and ethinyl estradiol vaginal system) to include revisions to its in vitro release testing specification that allow for normal manufacturing variability.
Annovera is a combined hormonal contraceptive vaginal ring indicated for use by females of reproductive potential to prevent pregnancy. The vaginal system remains in place continuously for 3 weeks (21 days) followed by a 1 week (7 day) vaginal system-free interval. One vaginal ring provides contraception for thirteen 28-days cycles.
According to the Company, the sNDA approval is expected to significantly reduce manufacturing batch rejections and increase future product supply. It is anticipated that an additional 7000 vaginal rings will be available in the second and third quarters of 2022.
“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, CEO of TherapeuticsMD.
- TherapeuticsMD receives US Food and Drug Administration (FDA) approval for supplemental New Drug Application (sNDA) for Annovera®. News release. TherapeuticsMD, Inc. Accessed May 20, 2022. https://www.businesswire.com/news/home/20220520005266/en/TherapeuticsMD-Receives-U.S.-Food-and-Drug-Administration-FDA-Approval-for-Supplemental-New-Drug-Application-sNDA-for-ANNOVERA%C2%AE
- Annovera. Package insert. TherapeuticsMD, Inc.; 2022. Accessed May 20, 2022. https://www.annovera.com/pi.pdf