USFDA has granted tentative approval for a FDC product containing lamivudine, nevirapine, and zidovudine, 150mg/200mg/300mg, indicated for use alone as a complete regimen, or in combination with other antiretrovirals, for the treatment of HIV-1 infection. This new FDC is manufactured by Strides Arcolab Limited, India. 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 US, 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. 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. A list of all FDA approvals and tentative approvals for PEPFAR can be found here
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