FDA approves Aurobindo HIV-1 generic

EAST WINDSOR, N.J. — The Food and Drug Administration approved Aurobindo Pharma’s Abacavir Sulfate and Lamivudine Tablets, 600 mg/300 mg. The Division of Bioequivalence determined Aurobindo Abacavir Sulfate and Lamivudine Tablets, 600 mg/300 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Epzicom Tablets of ViiV Healthcare.

Abacavir Sulfate and Lamivudine Tablets, 600 mg/300 mg is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. The product has an estimated market size of $346.3M for the 12 months ending February 2017 according to IMS.