Lupin arm gets supplemental new drug application approval from US regulator for Solosec

NEW DELHI: Drug firm Lupin on Thursday said it’s US-based arm has received approval from the US health regulator for its supplemental new drug application to expand the use of Solosec to include the treatment of trichomoniasis, a sexually transmitted disease.

The United States Food and Drug Administration (USFDA) has approved Lupin Pharmaceuticals, Inc’s supplemental new drug application (sNDA) to expand the use of Solosec to include the treatment of trichomoniasis in adults, Lupin said in a regulatory filing.

The drug was approved in the US in 2017 for the treatment of bacterial vaginosis in adult women, it added.

The supplemental approval makes Solosec the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and bacterial vaginosis, Lupin said.

“The FDA’s approval for the additional indication for SOLOSEC to treat trichomoniasis builds upon our commitment to support women’s health and provides health care professionals with an option to treat patients with trichomoniasis and bacterial vaginosis (BV),” Lupin Pharmaceuticals, Inc, Specialty – President, Jon Stelzmiller said.

Since trichomoniasis is a sexually transmitted disease, sexual partners should be treated with the same dose and at the same time, to prevent reinfection, Lupin said.

Shares of closed at Rs 1,146.25 per scrip on BSE, down 0.26 per cent from its previous close.