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lupin: Lupin gets tentative USFDA nod for Dolutegravir, Emtricitabine and Tenofovir Alafenamide tablets

Pharmaceutical firm Lupin Ltd on Tuesday said it has received tentative approval from the US health regulator for its new drug application Dolutegravir, Emtricitabine and Tenofovir Alafenamide (DETAF) tablets.

The tentative approval by the United States Food and Drug Administration (USFDA) has been granted under the President’s emergency plan for AIDS relief (PEPFAR), Lupin said in a regulatory filing.

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

“We are committed to providing affordable and quality treatment options to patients in low – and middle income countries,” Lupin President – API and Global Institution Business, Naresh Gupta said, adding the tentative approval by the USFDA for DETAF would significantly enhance the company’s HIV portfolio.

This product would be manufactured at Lupin’s Nagpur facility in India, the company said.

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