Lupin Pharmaceuticals Inc announced that the U.S. Food and Drug Administration has approved the company s supplemental New Drug Application (sNDA) to expand the use of SOLOSEC® (secnidazole) in the treatment of bacterial vaginosis (BV) for female patients 12 years of age and older and in the treatment of trichomoniasis for all patients 12 years of age and older. Bacterial vaginosis is a common vaginal infection and trichomoniasis is the most common non-viral, curable sexually transmitted infection in the U.S.1-4 The supplemental adolescent approval enhances SOLOSEC’s® strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV.
“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,” said Tom Merriam, Executive Director - Specialty, Lupin. “We are optimistic about this new treatment option for both healthcare practitioners and their adolescent patients.”
SOLOSEC® (secnidazole) 2g oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection, in female patients 12 years of age and older and trichomoniasis, a sexually transmitted infection, in patients 12 years of age and older. SOLOSEC® is designed to be easy to take and one oral dose contains a complete course of treatment.
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