Lupin Limited has been granted tentative approval by the US Food and Drug Administration (FDA) for its new drug application (NDA) for HIV drug cocktail – Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (TLD) Tablets, 50 mg/300 mg/300 mg, and antiretroviral fixed-dose combination (FDC).

The TLD product, which has been approved under the US President’s Emergency Plan for AIDS Relief (PEPFAR) will be manufactured at the company’s Nagpur facility in Maharashtra, India.

Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate is recommended by the US Agency for International Development (USAID), World Health Organisation (WHO), and PEPFAR as a preferred first-line treatment regimen for the treatment of HIV in adults and also pediatric patients, weighing at least 35 kg.

Lupin said that the HIV tablets will be available to be supplied to low-and-middle-income countries (LMIC).

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 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.”

Last month, Lupin had secured approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Luforbec (beclometasone dipropionate/formoterol fumarate dihydrate) 100/6 µg pressurized metered dose inhaler (pMDI).

  dolutegravir, HIV, India, lamivudine, Lupin, Maharashtra, Nagpur, Naresh Gupta, Tenofovir Disoproxil Fumarate, US FDA, US Food and Drug Administration, USA