Lupin Ltd, a leading Indian pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for the use of its antibiotic Solosec in adolescents for the treatment of bacterial vaginal infection and trichomoniasis, a sexually transmitted infection.
The US Food and Drug Administration (USFDA) has approved the company’s sNDA to expand the use of Solosec 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 above, Lupin Ltd said in a regulatory filing.
“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,” it said.
Commenting on the approval, Lupin Executive Director – Specialty, Tom Merriam said, “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…”
This will helps address gaps in care related to adherence and may reduce risk factors associated with BV and trichomoniasis, such as other sexually transmitted diseases, Merriam added.
Solosec is an oral antibiotic used to treat bacterial vaginosis in adult women and also in treating Trichomoniasis, a common sexually transmitted infection (STI), in adults.