PITTSBURGH — A subsidiary of Mylan has won approval to sell a generic drug for HIV and AIDS in developing countries under the President’s Emergency Plan for AIDS Relief.
Mylan announced Thursday that Matrix Labs won Food and Drug Administration approval for zidovudine tablets in the 100-mg strength. The drug is a generic version of ViiV Healthcare’s Retrovir, an antiretroviral sold as a water-dispersible tablet. The drug is designed to treat HIV and AIDS in children and prevent transmission of the virus from pregnant mothers to their children.
“According to PEPFAR, prevention of mother-to-child transmission of HIV is extraordinarily effective,” Mylan president Heather Bresch stated. “Without PMTCT, 25% to 40% of babies of HIV-positive mothers will be born infected; with PMTCT, that number drops to below 5%.”