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For Consumers

Tentative approval of lopinavir/ritonavir tablets, 200 mg/50 mg

On November 20, 2009, the Food and Drug Administration (FDA) granted tentative approval for a generic formulation of fixed dose combination lopinavir/ritonavir tablets, 200 mg/50 mg, made by Cipla Limited of Mumbai, India.  This dual protease inhibitor tablet is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

The application was reviewed under expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR).  FDA's tentative approval of this product means that although existing patents prevent marketing of this product in the United States, the product has been shown to meet all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S., and thus qualifies for consideration for purchase under PEPFAR .

This is a generic formulation of Kaletra, made by Abbott Laboratories, which is a dual protease inhibitor combination tablet. Effective patent date information is available in the FDA publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known 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 prior to granting approval or tentative approval to these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan (PEPFAR) 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

Page Last Updated: 08/20/2014
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