The company expects to launch the product in early September.
Phexxi is a non-hormonal, vaginal pH regulator contraceptive designed to maintain vaginal pH within the normal range of 3.5 to 4.5, an environment that is inhospitable to sperm, Evofem Biosciences said in a press release.
"The FDA approval of Phexxi means women now have access to a non-hormonal contraceptive option that they control, on their terms, to be used only when they need it," said Saundra Pelletier, chief executive of Evofem Biosciences. "Empowerment results from innovation and we are proud and excited to deliver new innovation to women in a category ready for change."
The list price for Phexxi will be $250 to $275 for a box of 12 without insurance, the company said.
Evofem Biosciences will host a conference call at 8:30 a.m. Tuesday to discuss the FDA approval of Phexxi.
Shares of Evofem Biosciences were rising 25.55% to $6.27 a share in trading Tuesday.
Oppenheimer analyst Leland Gershell has a buy rating on Evofem Biosciences with a price target of $23.
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