The Food and Drug Administration (FDA) today announced the tentative approval of two applications for nevirapine tablets manufactured by Ranbaxy Laboratories Limited, Guragon, India and Aurobindo Pharma Limited, Hyderabad, India. These are the first generic versions of Viramune Tablets manufactured by Boehringer Ingelheim. These products will now be available for consideration for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR).
“America is leading the global fight against HIV/AIDs and the scientists of our department are at the forefront of that effort,” said Health and Human Services Secretary Mike Leavitt. “The FDA, as well as others in our department and the administration, has been working diligently to make safe and effective treatments available at lower costs as quickly as possible to combat this worldwide problem. Working together, we’re helping reduce the pain and suffering of HIV/AIDS throughout the world.”
The Emergency Plan for AIDS Relief, which President Bush first announced in his 2003 State of the Union Address, is currently providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest hit countries. The PEPFAR plan is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children. It targets three specific areas related to HIV/AIDS:
* Prevention of HIV transmission;
* Treatment of AIDS and associated conditions;
* Care, including palliative care for HIV infected-individuals, and care for orphans and vulnerable children.
Nevirapine is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing. This antiretroviral drug is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The Agency’s tentative approval means that although existing patents and/or exclusivity prevent the marketing of Aurobindo’s and Ranbaxy’s products in the United States, these products meet all of FDA’s quality, safety and efficacy standards required for marketing in the United States. As such, they are now eligible to be considered for purchase and use outside the United States.
From U.S. FDA