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Tentative approval for abacavir sulfate scored tablets for oral suspension, 60 mg


On March 4, 2011, the Food and Drug Administration (FDA) granted tentative approval for abacavir sulfate scored tablets for oral suspension, 60 mg, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection in pediatric patients.

Reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR), this product is manufactured by Cipla Limited of Mumbai, 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.


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Source :

U.S. Food & Drug Administration 






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