February 5, 2014
FDA Approves Generic Reyataz for Use Abroad Via PEPFAR
The U.S. Food and Drug Administration has granted “tentative approval” to a generic formulation of Reyataz (atazanavir) to treat HIV abroad. The approval is for 100 milligram, 150 mg, 200 mg and 300 mg atazanavir capsules for use in combination with other antiretrovirals to treat HIV. The generic version of the Bristol-Myers Squibb medication is manufactured by Aurobindo Pharma in Hyderabad, India.
By granting only tentative approval, the FDA indicates that atazanavir has satisfied all quality, safety and efficacy standards but does not qualify for use in the United States because of existing patent protections on Reyataz. Instead, the drug will be available for purchase internationally through the President’s Emergency Plan for AIDS Relief (PEPFAR) program, which provides HIV care, prevention and treatment, among other services, to many hard-hit nations abroad.
To read the press release, click here.
Search: Food and Drug Administration, FDA, tentative approval, HIV, Reyataz, PEPFAR, atazanavir, generic, President's Emergency Plan for AIDS Relief, Aurobindo Pharma, Bristol-Myers Squibb, BMS
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