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news.The FDA has given tentative approval to Aurobindo Pharma's generic version of Bristol Myers Squibb's AIDS drug Sustiva.
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This product is the first tentatively approved generic version of Sustiva tablets. The drug will now be available for purchase under the President Bush’s Emergency Plan for AIDS Relief (PEPFAR), although it cannot be released onto the US market due to patent infringement.
The Emergency Plan for AIDS Relief 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.
Efavirenz is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing in cells. 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 exclusivity prevent marketing of these products in the US, they meet all of FDA’s quality, safety and efficacy standards required for marketing.