The Food and Drug Administration (FDA) announced the tentative approval of Stavudine (stav’ yoo deen) for Oral Solution, 1 mg/mL to be manufactured by Aurobindo Pharma LTD. of Hyderabad, India. 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 pediatric 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).
“All patients who depend on FDA-approved medicines are of great importance for our agency, but none more so than infants and children,” said Dr. Murray Lumpkin, the FDA Deputy Commissioner for International and Special Programs. “We take deep satisfaction in approving products that can bring much-needed relief to children infected with HIV.”
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.
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.