Lupin gets tentative US FDA nod for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (TLD) tablets under PEPFAR

Lupin announced that it has received tentative approval from the United States Food and Drug Administration (FDA) under the US President’s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (TLD) Tablets, 50 mg/300 mg/300 mg, and antiretroviral Fixed-Dose Combination (FDC). This product would be manufactured at Lupin’s Nagpur facility in India.

TLD is recommended by World Health Organisation (WHO), the US Agency for International Development (USAID), and PEPFAR as a preferred first-line treatment regimen for the treatment of HIV in adults and pediatric patients weighing at least 35 kg, and will be available for supplies to low-and- middle-income countries (LMIC).

Commenting on the USFDA tentative approval, Naresh Gupta, President, API Plus, Lupin said, “I am delighted that we have received FDA’s tentative approval for TLD. It is a significant approval for Lupin which has recently forayed into the HIV business arena. We have a deep commitment to increasing access to quality and affordable treatment options for low-and-middle-income countries for decades. Being integrated with in-house manufacture of APIs and formulations gives us an opportunity to provide quality products and uninterrupted supplies for affordable access for patients in these countries.”