Lupin Receives US FDA Tentative Marketing Approval for Generic Descovy Tablets

Lupin Receives US FDA Tentative Marketing Approval for Generic Descovy Tablets

By, Admin 1 August 2024

Overview

Global pharma major Lupin Limited 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 Abbreviated New Drug Application for emtricitabine and tenofovir alafenamide tablets, 200 mg/25 mg, to market a generic equivalent of Descovy tablets, 200 mg/25 mg, of Gilead Sciences, Inc.


 Product Manufacturing

  • This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries. 
  • Emtricitabine and tenofovir alafenamide tablets are indicated to treat or prevent HIV-1 infection in adults and children who weigh at least 35 kg.

Statement from Lupin

Naresh Gupta, president - API and Global Institution Business, Lupin said, “Lupin is committed to offering affordable, quality treatments for patients. The tentative approval from the US FDA for our emtricitabine and tenofovir alafenamide tablets significantly enhances our HIV medicine offering.

 About Lupin

  • 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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

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