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Aurobindo gets final approval for Abacavir tablets
Our Bureau, Mumbai | Tuesday, December 18, 2012, 15:00 Hrs  [IST]

Aurobindo Pharma has received final approval from the US Food and Drug Administration (FDA) to manufacture and market the earlier tentatively approved abacavir tablets USP 300 mg. Abacavir tablets is the generic equivalent of ViiV Healthcare Company's Ziagen tablets 300 mg and is is indicated as part of antiretroviral (ARV) combination therapy for the treatment of human immunodeficiency virus (HIV) infected adults and children. The annual sales o the product is approximately US$ 88 million.

The product has been approved out of Unit III formulations facility in Hyderabad. Aurobindo now has a total 167 ANDA approvals (141 final approvals including two from Aurolife Pharma LLC and 26 tentative approvals) from US FDA.

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