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HIV/AIDS Update - Tentative approval of lopinavir and ritonavir Oral Solution, 80 mg/20 mg per mL

Title: HIV/AIDS Update - Tentative approval of lopinavir and ritonavir Oral Solution, 80 mg/20 mg per mL

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You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

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On June 29, 2012, FDA granted tentative approval for lopinavir and ritonavir Oral Solution, 80 mg/20 mg per mL, reviewed under expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR).  It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

"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.  

This is a generic version of Kaletra® Oral Solution (Lopinavir and Ritonavir Oral Solution), 80 mg/20 mg per mL, a product of Abbott Laboratories, which is still subject to patent and exclusivity protection in the United States.

Patent information is available on line in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book.

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.

You can find a complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan on the FDA web site.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

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