Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market the earlier tentatively approved Abacavir Tablets USP 300mg (ANDA 077844) and is ready for launch. The product has been approved out of Unit III formulations facility in Hyderabad, India.
Abacavir Tablets USP 300mg is the generic equivalent of ViiV Healthcare Company’s Ziagen Tablets 300mg 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.
Aurobindo now has a total of 167 ANDA approvals 141 final approvals including 2 from Aurolife Pharma LLC and 26 tentative approvals from USFDA.
