Lupin Gets New Drug Approval for Solosec from US Regulator


On Thursday, 1st July 2021, the pharmaceutical company ‘Lupin’ said, the company’s subsidiary based in the United States have received the approval from the health regulator of the United States of America for the company’s new supplemental drug application for the purpose of expanding the use of the drug ‘Solosec’ for the treatment of trichomoniasis, which is a sexually transmitted disease.

In a regulatory filing, Lupin said, the United States Food and Drug Association (USFDA) has given the approval to the supplemental new drug application (sNDA) of Lupin Pharmaceutical Inc., for expansion of the use of Solosec for the treatment of trichomoniasis in the adults of United States.

Lupin also said, the drug was approved in 2017 in the United States for the purpose of treating the bacterial vaginosis in the adult women, and this approval of Solosec from USFDA has made the drug the first and only single-dose oral antimicrobial prescription agent, which had got the approval for the treatment of bacterial vaginosis and trichomoniasis.

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Jon Stelzmiller, president of Lupin Pharmaceutical Inc., said, the approval from FDA to the additional indication for the drug ‘Solosec’ for the treatment of trichomoniasis is building their commitment for providing support to the women’s health, and it also provides specialized healthcare professionals along with an option for the treatment of the patients suffering from bacterial vaginosis and trichomoniasis.

The company added, as trichomoniasis is a sexually transmitted disease (STD), the sexual partners should be treated with the similar dose and at the same time for providing prevention from being re-infected.