FDA Approves Vaginal Gel for Treatment of Bacterial Vaginosis
SAN DIEGO - Food and drug administration has approved Xaciato, a vaginal gel, for the treatment of bacterial vaginosis in females aged 12 years or older. The approval of Xaciato (clindamycin phosphate vaginal gel, 2%) formerly known as DARE-BVI has been granted to Daré Bioscience.
"The FDA approval of XACIATO marks a major milestone not only for Daré as a company but, importantly, for the 21 million women impacted by bacterial vaginosis," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "It is our goal as a company to accelerate the development of differentiated products that can improve outcomes and convenience for women. In the case of XACIATO, this FDA approval comes just three years after we licensed this technology. We are grateful to the FDA for their thoughtful review and the alignment on labeling. We hope that this is the first of many FDA approvals in our efforts to improve the lives of women with treatment options that address some of the most persistent unmet needs."
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