2 July, 2005: Aurobindo Pharma has received the US Food and Drug Administration's tentative approval of its Stavudine Capsules versions. The Aurobindo product is the first generic version of the already approved Zerit capsules brand of Stavudine made by Bristol-Myers Squibb. The tentative FDA approval means that this Aurobindo Pharma generic drug will now be available for consideration for purchase and use outside the US under the President's Emergency Plan for AIDS Relief (PEPFAR).
According to Health and Human Services Secretary Mike Leavitt, "We are pleased to announce another completed drug review by HHS and the Administration in our continuing efforts to make available safe and effective AIDS treatments. Stavudine is another treatment in the expanding arsenal in the
global fight against AIDS."
The Emergency Plan for AIDS Relief, which American President George Bush first announced in his 2003 State of the Union Address, is now 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 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
Stavudine comes under the class of medicines called Nucleoside Reverse Transcripts Inhibitors (NRTIs). NRTIs help keep the AIDS virus from reproducing. In combination with other antiretroviral agents for the
treatment of HIV-1 infection, Stavudine can be used.
The FDA nod for the Aurobindo drug means that although existing patents and/or
exclusivity prevent marketing of these products in the U.S., these drugs meet all
of FDA's quality, safety and efficacy standards.
BY OUR PHARMA CORRESPONDENT