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On March 17, 2014, FDA granted tentative approval for atazanavir sulfate and ritonavir Fixed-Dose Combination tablets 300 mg/100 mg, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and pediatric patients at least 6 years of age and weighing 40 kg. The application was filed by Emcure Pharmaceuticals Limited of Pune, India.
"Tentative approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. Tentative approval does, however, make the product eligible for purchase outside the United States under the PEPFAR program.
The application was reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR).
A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA web site.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
For other information of interest to patients and patient advocates, see FDA's Patient Network web site.
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