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Aurobindo Receives FDA Approval for Darunavir Tablets, 600 mg and 800 mg

Published: November 28, 2023

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Darunavir Tablets, 600 mg and 800 mg. Aurobindo Pharma’s Darunavir Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Prezista Tablets manufactured by Janssen Products, L.P.

Darunavir Tablets are indicated for:

  • Co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older.