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TherapeuticsMD Inc (NASDAQ: TXMD) shares are trading higher after FDA approved the supplemental application, including minor revisions to Annovera's in vitro release testing specification that allowed for normal manufacturing variability.
The FDA approved Annovera in August 2018 as the only long-lasting, reversible, procedure-free birth control.
With the approval of the supplemental application, the company believes approximately 7,000 additional rings will be able to enter the supply chain and be available to customers in the Q2 and Q3 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, Chief Executive Officer of TherapeuticsMD.
Price Action: TXMD shares are up 26.4% at $2.87 during the market session on the last check Friday.
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