NEW DELHI: Drug major Cipla has received approval from the US health regulator for its generic Abacavir and Lamivudine tablets used for treatment of human immunodeficiency virus (HIV) infection.
The company "has received final approval for its abbreviated new drug application (ANDA) for Abacavir and Lamivudine tablets USP 600 mg/300 mg from the United States Food and Drug Administration (USFDA)", Cipla said in a filing to BSE. The product is generic version of ViiV Healthcare Company's Epzicom tablets in the same strengths, it added.
The tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection, Cipla said. "Epzicom tablets had US sales of approximately USD 346.3 million for the 12 month period ending February 2017, according to IMS Health", it added.
The product will cater to the US market and will be commercially available shortly, Cipla said.
Cipla's portfolio currently includes over 1,000 products across a wide range of therapeutic categories.