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Lupin bags US FDA approval for DETAF tabs

The product will be manufactured at Lupin’s Nagpur facility

Lupin 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, Emtricitabine and Tenofovir Alafenamide (DETAF) tablets. The product will be manufactured at Lupin’s Nagpur facility. 

DETAF would be a welcome new addition to the management of HIV infections and will be available for supplies to low and middle-income countries.

Naresh Gupta, President, API and Global Institution Business, Lupin said, “We are committed to providing affordable and quality treatment options to patients in low- and middle-income countries. We are pleased that US FDA has tentatively approved DETAF, which will significantly enhance our HIV portfolio.”

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