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Tentative approval of fixed dose combination lamivudine, nevirapine, and zidovudine tablets for Oral Solution, 30 mg/50 mg/60 mg)
  On July 8, 2010, granted tentative approval for a fixed dose combination product of lamivudine, nevirapine, and zidovudine tablets For Oral Solution, 30 mg/50 mg/60 mg) indicated in combination with other antiretrovirals for the treatment of HIV-1 infection in pediatric patients, manufactured by Matrix Laboratories Limited of Hyberdad, India. This is the first tentative approval of this fixed dose combination product for pediatric use.
Each constituent ingredient of this generic tablet is currently approved to treat HIV-1 in combination with other antiretroviral agents. The safety and effectiveness of the combination of lamivudine/nevirapine/zidovudine in lowering viral load and increasing CD4+ cells has been demonstrated in previous studies of the individual ingredients used together.
FDA's tentative approval means that although a product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., existing patents and/or proprietary issues currently prevent marketing of the product in the United States. Tentative approval, however, does qualify the product for consideration for purchase under the President's Emergency Plan for AIDS Relief, or PEPFAR program.
As with all generic applications, FDA conducts an on-site inspection of the manufacturing facilities 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.
These products were reviewed for PEPFAR under the FDA guidance titled Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously approved Antiretrovirals for the Treatment of HIV developed to clarify what regulatory requirements apply to such applications, what issues might be of concern, and how these issues should be addressed. The guidance is intended to encourage sponsors to submit applications for combination and co-packaged products, and to facilitate submission of such applications to FDA. The pediatric indication, fulfilling unmet medical need, qualified this tentative approval priority review.
A list of all FDA approvals and tentative approvals for PEPFAR can be found 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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