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Tentative approval of lopinavir and ritonavir tablets 200 mg/50 mg (PEPFAR)

<p>Richard Klein &amp; Kelly Struble</p>


May 24, 2012

On May 23, 2011, FDA granted tentative approval under expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR) for a generic version of lopinavir and ritonavir tablets 200 mg/50 mg. 

The product, manufactured by Hetero Labs Limited, Hyderabad, India, and indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection, is a generic formulation of Kaletra® tablets, 200 mg/50 mg, made by Abbott Laboratories.

"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.

As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility, and of the facilities performing the bioequivalence studies, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications.

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 Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration



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