Aurobindo Pharma Limited, based in Hyderabad, India, announced it received a tentative approval for HIV drug Dolutegravir from the U.S. Food & Drug Administration.
It is reportedly the first FDA approval of a generic version of Dolutegravir, according to an article in Real Time News-India. The product is projected to launch later this year in sub-Saharan Africa.
“This is a one-of-its-kind agreement between innovator and generic company where the generic version of the drug will be launched in around three years from the originator product. Further, we are also developing a fixed dose combination of DTG,” said N. Govindarajan, Managing Director of Aurobindo Pharma Limited.
The story explains tentative approvals are given for generic versions of drugs that continue to still have patent protection and cannot be marketed purely on the basis of these approvals.
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