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Hyderabad based Aurobindo Pharma Limited (APL) has received final approval from the United States Food and Drugs Administration (FDA) to manufacture Abacavir sulfate and Lamivudine tablets, used for the treating patients infected with human immunodeficiency virus (HIV).
According to a release from APL, the company has got the US FDA nod to manufacture Abacavir sulfate 600 mg and Lamivudine 300 mg tablet used for treating HIV patients. Soon after receiving the news of FDA approval the company sources have decided to immediately launch the product. “We have got the final approval from US FDA for the manufacture of two HIV drugs viz., Abacavir sulfate and Laminvudine tablets. And we have decided to launch both the products with immediate effect,” informed a spokes person from Aurobindo Pharma.
The approved product is AB rated generic equivalent of VIIV Healthcare’s Epzicom tablet. It has an estimated market size of $ 388 million for 12 months ended December 2016, APL 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 Pharma now has a total of 314 ANDA approvals (276 final approvals including 16 from Aurolife Pharma LLC and 38 tentative approvals) from the US FDA.
Aurobindo’s hiv drugs, abacavir & lamivudine, us fda approval
