FDA Tentatively Approves a Generic AIDS Drug in Association with the Presidents Emergency Plan for AIDS Relief

The Food and Drug Administration (FDA) today announced the tentative approval of the drug product Lamivudine Oral Solution, 10 mg/mL manufactured by Aurobindo Pharma LTD. of Hyderabad , India . Lamivudine Oral Solution is the first generic version of the already approved Epivir Oral Solution, 10 mg/mL, manufactured by GlaxoSmithKline. This child-friendly-product is indicated for use in pediatric patients with HIV from three months to 16 years, and will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief.

"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.

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 President's plan is designed to prevent 7 million new HIV infections, treat at least 2 million HIV-infected people, and care for 10 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

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.

FDA's tentative approval of this product means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the products meet all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S.

Source: FDA