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news.The FDA has issued the first tentative approval for a three-ingredient fixed-dose tablet for use as a stand-alone antiretroviral treatment HIV infection in adults.
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The product (lamivudine-zidovudine-nevirapine tablet) contains the active ingredients in GlaxoSmithKline’s Epivir (lamivudine) and Retrovir (zidovudine), and Boehringer Ingelheim’s Viramune (nevirapine), all widely used antiretroviral drugs.
The agency’s tentative approval means that although existing patents and/or exclusivity prevent approval of this product in the US, it meets all of the FDA’s manufacturing quality and clinical safety and efficacy standards required for marketing in the US. The fixed-dose combination tablet, manufactured by India’s Aurobindo Pharma, will be available for purchase and distribution in 15 other countries under the President’s Emergency Plan for AIDS Relief (PEPFAR).
In 2004, FDA issued a guidance encouraging manufacturers to develop fixed-dose combination and co packaged products consisting of previously approved antiretroviral therapies for the treatment of HIV infection. The FDA has committed to reviewing applications submitted pursuant to this guidance in an expedited manner.
The recommended regimen for the lamivudine-zidovudine-nevirapine tablet is one pill twice a day following an initial two-week treatment with the individual components taken individually. Each ingredient of this generic tablet is currently approved to treat HIV-1 infected adults in combination with other antiretroviral agents.