PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic drug for HIV/AIDS made by Mylan subsidiary Matrix Labs for distribution in developing countries under the President’s Emergency Plan for AIDS Relief, Mylan said Tuesday.
The tentative approval under PEPFAR covers Matrix’s abacavir sulfate tablets in the 60-mg strength. The drug is a generic version of ViiV Healthcare’s Ziagen, and is used to treat the disease in children.
“This approval is particularly important because it adds to the available treatment options for children who are living with HIV/AIDS in developing countries,” Mylan president Heather Bresch said. “The addition of abacavir to Mylan and Matrix’s HIV/AIDS antiretroviral franchise is a critical next step in helping to extend and improve the quality of life of people living with HIV/AIDS, and to continue to expand access to high-quality, affordable ARVs.”