Lupin gets USFDA tentative approval for its new drug application

Lupin Ltd, a leading pharmaceutical company, announced today that it has received tentative approval from United States Food & Drug Administration (USFDA) for its new drug application for Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate (TLD) tablets. Along with this, it also received approval for antiretroviral fixed-dose combination (FDC).  

USFDA approval falls under US President's Emergency Plan for AIDS Relief (PEPFAR). Dolutegravir will be available in 50 mg strength whereas Lamivudine & Tenofovir Disoproxil Fumarate tablets would be available in the strength of 300 mg each. These tablets will be manufactured at the company’s Nagpur facility. 

The new drug application-TLD has been recommended by various organisations such as World Health Organisation (WHO), United States Agency for International Development (USAID), and PEPFAR. It is a preferred primary therapy for treating HIV in adults and pediatric patients weighing at least 35 kilograms. The TLD tablets will be available for supplies to lower and middle-income countries (LMIC). 

At 11.35 am, the share price of Lupin Ltd was trading at Rs 1,153.90, which was a decrease of 0.61 per cent over its previous day’s trading price of Rs 1,161 on BSE.