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Tenative approval of lamivudine/zidovudine
fixed dose combination tablets plus nevirapine tablets
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In May 7, 2009, using expedited review procedures developed to support the President's Emergency Program For AIDS Relief (PEPFAR), FDA granted tentative approval for lamivudine/zidovudine fixed dose combination tablets, 150 mg/300 mg, co-packaged with nevirapine tablets, 200 mg. The product, indicated for use alone as a complete regimen, or in combination with other antiretroviral agents for the treatment of HIV-1 infection, is manufactured by Hetero Drugs Limited of Hyberdad, India.
FDA's tentative approval of this product means that while FDA cannot fully approve the product for sale in the United States because of existing patent protections, it has been shown to meet all of FDA's safety, efficacy and manufacturing quality standards. Tentative approval, signifying that the standards have been met, qualifies the product for consideration for purchase using PEPFAR funds.
Both lamivudine and zidovudine are members of the Nucleoside Reverse Transcriptase Inhibitor (NRTI) class of antivirals. Nivirapine is a Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI).
Fixed dose combination and co-packaged products such as this can help ease pill burden and simplify therapy, and may help increase adherence to therapeutic regimens, potentially reducing development of resistance to the separate drugs.
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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