Lupin obtains tentative nod from FDA for dolutegravir lamivudine and tenofovir alafenamide

Lupin has received tentative approval from the Food and Drug Administration under the U.S. President’s Emergency Plan for AIDS Relief for dolutegravir lamivudine and tenofovir alafenamide tablets.

This product, which is a generic of ViiV Healthcare's Dovato, would be manufactured at Lupin’s Nagpur facility in India.

[Read more: Lupin receives FDA OK for generic Banzel]

Naresh Gupta, president of API and global institution business at Lupin said, “At Lupin, we are unwavering in our commitment to providing affordable and quality treatment options for patients in low and middle-income countries. We are pleased to receive the U.S. FDA’s tentative approval of dolutegravir lamivudine and tenofovir alafenamide tablets, which significantly bolsters our HIV portfolio.”

[Read more: Lupin receives tentative nod from FDA for DETAF]