Lupin receives tentative US FDA approval for HIV drug under PEPFAR

Global pharma major Lupin Limited today announced that it has received tentative approval from the US health regulator to market HIV treatment medication in the American Market.

In a regulatory filing at BSE, Lupin said, "It has received tentative approval from the United States Food and Drug Administration (FDA) under the U.S. 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 U.S. 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, Mr. 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."

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across the Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.