Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Abacavir Sulfate and Lamivudine tablets, 600 mg/300 mg.
Aurobindo’s Abacavir Sulfate and Lamivudine tablets are the AB rated generic equivalent of VIIV Healthcare Company’s Epzicom tablets. The product is being launched immediately.
Abacavir Sulfate and Lamivudine tablets are indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection. The approved product has an estimated market size of US$ 388 million for the twelve months ending December 2016 according to IMS.
This is the 108th ANDA (including 20 tentative approvals) approved out of Unit VII formulation facility in Hyderabad, India 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.