Mylan’s Atazanavir/Ritonavir Tablets Garner Tentative FDA Approval Through PEPFAR

Mylan announced that the FDA has granted tentative approval through the President’s Emergency Plan for AIDS Relief (PEPFAR) for its heat-stable atazanavir sulfate/ritonavir tablets for the treatment of HIV infection and AIDS. The World Health Organization has also prequalified this product as a second-line treatment option to be used in combination with other antiretrovirals for the treatment of HIV/AIDS.

Atazanavir/ritonavir will be available for purchase in a 300mg/100mg dosage strength outside the U.S. in certain developing countries.

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