Aurobindo Pharma on Thursday said it has received final approval from the US health regulator to manufacture abacavir sulfate and lamivudine tablets, 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," Aurobindo Pharma said in a BSE filing.
The company said the product is being launched immediately. The approved product is AB rated generic equivalent of VIIV Healthcare Company's Epzicom tablet. It has an estimated market size of USD 388 million for the 12 months ended December 2016, Aurobindo Pharma said, citing market research reports.
This is the 108th ANDA (including 20 tentative approvals) approved out of Unit VII formulation facility in Hyderabad, used for manufacturing oral products.
Aurobindo now has a total of 314 ANDA approvals (276 Final approvals including 16 from Aurolife Pharma LLC and 38 tentative approvals) from USFDA. The stock of Aurobindo Pharma was trading 0.98 per cent higher at Rs 678 on the BSE.