Under PEPFAR, Matrix gets tentative approval for generic Combivir

PITTSBURGH — The Food and Drug Administration has given tentative approval to an antiretroviral treatment for children with HIV and AIDS under the President’s Emergency Plan for AIDS Relief program.

Mylan announced Thursday that its subsidiary, Matrix Labs, had received the tentative approval for lamivudine and zidovudine tablets in the 30-mg/60-mg strength. The drug is a generic version of Combivir, made by ViiV Healthcare, a company specializing in HIV and AIDS created as a partnership between Pfizer and GlaxoSmithKline.

“The approval of lamivudine and zidovudine is particularly important because it makes available an innovative [fixed-dose combination] treatment option for children who are living with HIV/AIDS in developing countries,” Mylan president Heather Bresch said.