The Food and Drug Administration (FDA) announced the tentative approval of Stavudine 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 7 million new HIV infections, treat at least two 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
In support of the President's plan, the Office of Generic Drugs (OGD), within the FDA's Center 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. FDA staff, including members of CDER's OGD, Division of Antiviral Drug Products, and FDA's Office of Regulatory Affairs developed a focused, interactive approach to the product development and application review process to diligently resolve any issues that would delay the submission of and the completion of the review of a quality marketing application. The success of this process has been demonstrated by the number of quality, safe and effective generic products available for consideration for purchase by the President's plan.
"We are very pleased to be able to make this important pediatric formulation of Stavudine available to the patients being helped by President Bush's Emergency Plan for AIDS Relief," said Gary J. Buehler, director of CDER's Office of Generic Drugs. "FDA's action on this application adds another critical product to the arsenal of drugs available for the global fight against HIV/AIDS."
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.
The agency's tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the United States, it meets all of FDA's manufacturing quality and clinical safety and efficacy standards required for marketing in the United States. As with all generic applications before granting approval or tentative approval, FDA conducts an on-site inspection of each manufacturing facility and the facilities performing the bioequivalence studies. The inspection assesses the ability of the manufacturer to produce a quality product, and the quality of the bioequivalence data supporting the application.