Lupin gets FDA approval of sNDA for Solosec

Lupin Pharma yesterday announced that the US Food and Drug Administration (FDA) 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, Lupin notified via a statement.

The statement also informed that BV is a common vaginal infection and trichomoniasis is the most common non-viral, curable sexually transmitted infection in the US. The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription anti-microbial 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 healthcare 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 adherence, and may reduce risk factors associated with BV and trichomoniasis, such as other Sexually Transmitted Diseases (STIs),” said Tom Merriam, Executive Director – Specialty, Lupin, in the statement.