Aurobindo Pharma Limited, a city-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market the earlier tentatively-approved Abacavir tablets in 300 mg strength.
The product, which has been approved out of Aurobindo’s Unit-III formulations facility in Hyderabad, is ready for launch, the company said in a filing to the BSE on Tuesday.
The generic equivalent of ViiV Healthcare Company’s Ziagen tablets, Abacavir is indicated as part of anti-retroviral 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 (abbreviated new drug application) approvals, including 141 final approvals (including 2 from Aurolife Pharma LLC), and 26 tentative approvals from the US FDA.
Aurobindo’s scrip is currently trading at Rs 189 on the BSE, up 1.04%, over the previous close of Rs 187.05 a share.