Lupin gets USFDA’s tentative approval for Dolutegravir, Lamivudine and TLD Tablets

30 Jun 2021 Evaluate

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) 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).

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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