Aurobindo Pharma receives USFDA’s approval for Lamivudine, Zidovudine Tablets

16 May 2012 Evaluate

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Lamivudine and Zidovudine Tablets USP 150/300mg and is ready for launch. The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India.

Lamivudine and Zidovudine Tablets USP 150/300mg is the generic version of ViiV Healthcare Company’s Combivir Tablets USP 150/300mg 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 about $265 million.

The company now has a total of 150 ANDA approvals (122 Final approvals including 1 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.

Aurobindo Pharma has a product presence in key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardio-vascular, gastroenterology, etc. The company is the market leader in semi-synthetic penicillin drugs.

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