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news.The FDA has tentatively approved the first generic version of GlaxoSmithKline's AIDS drug Epivir oral solution indicated for use in pediatric patients with HIV from three months to 16 years.
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The generic version is named lamivudine and is manufactured by Aurobindo Pharma of India. According to the FDA, the copycat product will now be available for consideration for purchase under President Bush’s emergency plan for AIDS relief.
Lamivudine is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This antiretroviral drug is intended to be used with other antiretroviral agents for the treatment of HIV-1 infection.
The President’s 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 plan aims 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.
“FDA’s action today demonstrates our continuing commitment to the President’s Emergency Plan by ensuring that safe, effective, and quality manufactured medications for children are also available for purchase under the President’s Plan,” said acting FDA commissioner Dr Andrew von Eschenbach.