New Delhi: Drug firm Zydus Cadila on Tuesday said it has received the tentative approval from the US health regulator to market Abacavir and Lamivudine tablets, used for treatment of HIV.
The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market Abacavir and Lamivudine tablets USP in the strength of 600 mg/300 mg, Zydus Cadila said in a statement.
The tablets are indicated for use in antiretroviral combination therapy for treatment of human immunodeficiency virus (HIV) infection, it added.
The tablets “will be produced at the group’s formulations manufacturing facility at the Pharma SEZ in Ahmedabad”, Zydus Cadila said.
The group now has more than 130 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs), it added.