Xaciato FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 8, 2021.
FDA Approved: Yes (First approved December 7, 2021)
Brand name: Xaciato
Generic name: clindamycin phosphate
Dosage form: Vaginal Gel
Previous Name: DARE-BV1
Company: Organon Pharmaceuticals
Treatment for: Bacterial Vaginosis
Xaciato (clindamycin phosphate) is a topical lincosamide antibacterial for the vaginally-administered treatment of bacterial vaginosis in female patients 12 years of age and older.
- Xaciato is a thermosetting bioadhesive hydrogel formulation of clindamycin phosphate 2% for the treatment of bacterial vaginosis via a single application. It is a viscous liquid designed to undergo solution to gel (sol-to-gel) transition using body temperature as the trigger. This property allows the product to be more easily directed to the site of infection.
- Xaciato is administered once intravaginally as a single dose at any time of the day.
- Xaciato may cause serious adverse reactions including Clostridioides difficile-associated diarrhea. Common adverse reactions include vulvovaginal candidiasis and vulvovaginal discomfort.
Development timeline for Xaciato
Further information
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