Lupin Announces FDA Approval of Supplemental New Drug Application for SOLOSEC® (secnidazole) in Adolescents for both the Treatment of Bacterial Vaginosis in Females and Trichomoniasis
Retrieved on:
Thursday, February 17, 2022
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"The FDA's approval expands the indication for SOLOSEC to treat adolescents and builds upon our commitment to support women's health.
Key Points:
- "The FDA's approval expands the indication for SOLOSEC to treat adolescents and builds upon our commitment to support women's health.
- Vulvovaginal candidiasis may develop with SOLOSEC and require treatment with an antifungal agent.
- To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
- SOLOSEC is a registered trademark of Lupin Inc. and LUPIN is a registered trademark of Lupin Pharmaceuticals, Inc.