Mylan receives tentative approval for HIV/AIDS drug in developing countries

PITTSBURGH — The Food and Drug Administration has given tentative approval to a division of Mylan for a generic drug for treating HIV and AIDS in children in developing countries.

Mylan said Thursday that the FDA had tentatively approved Mylan Labs' abacavir sulfate and lamivudine tablets in the 60 mg/30 mg strength. The drug is a generic version of Viiv Healthcare's Epzicom and was approved under the President's Emergency Plan for AIDS Relief. The drug will only be available for purchase in certain developing countries outside the United States.

"The approval of abacavir sulfate and lamivudine further supports Mylan's mission to continue expanding access to high-quality medicine around the world, which is especially crucial for children living with HIV/AIDS," Mylan CEO Heather Bresch said. "This product combines two medications in one tablet, which may support treatment adherence in children as it reduces the pill burden often associated with complex antiretroviral regimens."

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