Lupin Announces FDA Approval of Supplemental New Drug Application for SOLOSEC

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The US Food and Drug Administration approved Lupin Pharmaceuticals Inc.’s supplemental New Drug Application (sNDA) on Thursday to expand the use of SOLOSEC (secnidazole) in the treatment of bacterial vaginosis (BV) in female patients 12 years of age and older, as well as in the treatment of trichomoniasis in all patients 12 years of age and older. In the United States, bacterial vaginosis is the most frequent vaginal infection, while trichomoniasis is the most common nonviral, curable sexually transmitted illness.1-4 SOLOSEC’s strong position as the first and only single-dose oral prescription antibacterial medication licensed for the treatment of both trichomoniasis and BV is strengthened by the supplementary teenage approval.

“The FDA’s approval expands the indication for SOLOSEC to treat adolescents and builds upon our commitment to support women’s health. This expansion brings to health care professionals a treatment option for both BV and Trichomoniasis in Adolescents which provides a complete course of therapy in a single dose, one which helps to address gaps in care related to adherence5, and may reduce risk factors associated with BV and trichomoniasis6-7, such as other sexually transmitted diseases (STIs)8-9. We are optimistic about this new treatment option for both healthcare practitioners and their adolescent patients,”

said Tom Merriam, Executive Director – Specialty, Lupin.
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