Aurobindo Pharma has received the final approval from the US Food and Drug Administration (US FDA) to manufacture and market the earlier tentatively approved Abacavir tablets USP 300mg (ANDA 077844) and is ready for launch.
Abacavir tablets USP 300mg is the generic equivalent of ViiV Healthcare Company’s Ziagen tablets 300 mg 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.
Aurobindo now has a total of 167 ANDA approvals (141 Final approvals including two from Aurolife Pharma LLC and 26 Tentative approvals) from US FDA.
EP News Bureau– Mumbai