USFDA nod to Aurobindo Pharma for manufacturing HIV drug

Picture taken on January 15, 2012 in Lille, northern France, of drug capsules. AFP PHOTO PHILIPPE HUGUEN (Photo credit should read PHILIPPE HUGUEN/AFP/Getty Images)

Hyderabad-based pharmaceutical major Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to make abacavir sulfate and lamivudine tablets, which are used in the treatment of HIV.

“The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture abacavir sulfate and lamivudine tablets, 600 mg/ 300 mg,” the company said in a BSE filing.

The product, with an estimated market size of $388 million, will be launched immediately, according to the Indian pharma major.

With this, Aurobindo Pharma now has a total of 314 ANDA approvals from the US drug regulator.


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