Mylan generic drug for HIV/AIDS receives tentative FDA approval through PEPFAR

Agency grants tentative approval to atazanavir/ritonavir combination pill

PITTSBURGH — Under the President's Emergency Plan for AIDS Relief, the Food and Drug Administration has given tentative approval to a generic HIV and AIDS drug made by Mylan, the company said.

The drug maker's Mylan Labs subsidiary received tentative approval for atazanavir sulfate and ritonavir tablets in the 300-mg/100-mg strength. The FDA's tentative approval of the drug under PEPFAR means it will be eligible for purchase in certain developing countries.

Mylan said the drug was the first heat-stable, fixed-dose combination of the two drugs. The World Health Organization also "pre-qualified" the drug as a second-line treatment option for HIV and AIDS, the company said.

Atazanavir sulfate is a generic version of Bristol-Myers Squibb's Reyataz, while ritonavir is a generic version of Abbott Labs' Norvir.


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