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HIV/AIDS Update – Tentative approval of lopinavir/ritonavir Tablets , 200 mg/50 mg

On March 10, 2009, FDA granted tentative approval for a generic formulation of lopinavir/ritonavir Tablets, 200 mg/50 mg, manufactured by Matrix Laboratories, Ltd., of Hyderabad, India, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.

This 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 meets all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patents. Tentative approval, however, does make the product eligible for consideration for purchase outside the United States under the President’s Emergency Plan for AIDS Relief (PEPFAR) .

Effective patent dates can be found in the agency’s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the “Orange Book.”

This application was reviewed under expedited review provisions developed by FDA for 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 list of all Tentatively Approved Antiretrovirals in Association with the President’s Emergency Plan is available on the FDA website.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration


March 11, 2009 - Posted by | 1

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