Food and Drug Administration - August 9, 2007
Richard Klein & Kimberly Struble

FDA granted tentative approval on August 8, 2007 for a generic formulation of a combination product, lamuvidine and zidovidine tablets, 150 mg/300 mg, manufactured by Emcure Pharmaceuticals Inc. of Pune, India, under expedited review provisions developed for the President's Emergency Plan for AIDS Relief (PEPFAR).

"Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, even though it may not yet be marketed in the U.S. because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible for consideration for purchase under the PEPFAR program.

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

This is a generic formulation of FDA approved Combivir Tablets, 150 mg/300 mg, marketed by GlaxoSmithKline, which is subject to patent and pediatric exclusivity protections.

Effective patent dates and additional marketing exclusivities can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"

Lamuvidine and zidovidine are both Nucleoside Reverse Transcriptase Inhibitors (NRTI) indicated for used in combination with other antiretroviral agents in the treatment of HIV infection.

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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SOURCE: Food and Drug Administration (FDA).

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