The United States Food and Drug Administration (FDA) has given a tentative approval of stavudine oral solution, 1 mg/ml to be manufactured by Aurobindo Pharma.
This product is the first generic version of the already approved Zerit for oral solution manufactured by Bristol-Myers Squibb. This child-friendly product is indicated for use in paediatric patients with HIV, from birth through adolescence. This product will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).
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 President's 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.
In support of the president's plan, the Office of Generic Drugs (OGD), within the FDA's Centre for Drug Evaluation and Research (CDER), has approved or tentatively approved over a dozen applications for a number of products to treat HIV/AIDS through an innovative product development and expedited application review process.
Stavudine (d4T) is active against the human immunodeficiency virus (HIV) that causes AIDS. It is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This antiretroviral drug is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.