Aurobindo Pharma has received final approval from the US FDA to manufacture and market Lamivudine and Zidovudine tablets USP 150/300 mg (ANDA 202418) and is ready for launch.
Lamivudine and Zidovudine tablets USP 150/300 mg is the generic equivalent of ViiV Healthcare Company’s Combivir Tablets USP 150/300 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 $ 265 million.
The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India. Aurobindo now has a total of 150 ANDA approvals (122 final approvals including one from Aurolife Pharma LLC and 28 tentative approvals) from US FDA.
EP BUREAU – Mumbai
