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On October 16, 2012, FDA granted tentative approval for lamivudine, nevirapine and zidovudine fixed dose combination scored tablets for Oral Suspension, 30 mg/50 mg/60 mg, indicated alone or in combination with other antiretrovirals for the treatment of HIV-1 infection in children weighing 5 to 25 kg.
"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.
Lamivudine, nevirapine and zidovudine is a combination of two nucleoside analog HIV-1 reverse transcriptase inhibitors (lamivudine and zidouvine) and one non-nucleoside analogue reverse transcriptase inhibitor (nevirapine).
The product is manufactured by Cipla Limited of Mumbai, India, and was reviewed 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 the regulatory requirements that apply to such applications, possible issues of concern, and how they 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.
A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available 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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