Drug firm Aurobindo Pharma today said it has received US health regulator's final approval to market Abacavir Tablets, used in the treatment of Human Immunodeficiency Virus (HIV), in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market the earlier tentatively approved Abacavir Tablets USP 300mg and is ready for launch, Aurobindo Pharma said in a filing to BSE.
Abacavir Tablets USP in strength of 300 mg is the generic equivalent of ViiV Healthcare Company's Ziagen and is indicated as part of antiretroviral (ARV) combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children.
"The annual sale of the product is approximately $88 million. The product has been approved out of Unit III formulations facility in Hyderabad, India," the company said.
Aurobindo now has a total of 167 abbreviated new drug application (ANDA) approvals from the USFDA.
Shares of Aurobindo Pharma in BSE closed at Rs190.85on Tuesday, up 2.03 per cent from its previous close.