Lupin announces FDA Approval of Supplemental New Drug Application for SOLOSEC®

Lupin Pharmaceuticals Inc., (Lupin) today 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. 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 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. "We are optimistic about this new treatment option for both healthcare practitioners and their adolescent patients."

Shares of Lupin Limited was last trading in BSE at Rs. 771.55 as compared to the previous close of Rs. 777.75. The total number of shares traded during the day was 43830 in over 2456 trades.

The stock hit an intraday high of Rs. 788.00 and intraday low of 766.80. The net turnover during the day was Rs. 33803759.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 sNDA USFDA SOLOSEC Secnidazole BacterialVaginosisTreatment