[Savannah-help-public] BMN PRESS RELEASE: FDA Tentatively Approves a Generic AIDS Drug in Association with the President's Emergency Plan for AIDS Relief

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FDA TENTATIVELY APPROVES A GENERIC AIDS DRUG IN ASSOCIATION WITH THE 
PRESIDENT'S EMERGENCY PLAN FOR AIDS RELIEF
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COSTA MESA CA USA -- MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM) -- DEC 28 2005 -- 
The US FDA has tentatively approved a new AIDS drug, Stavudine 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, officials explained. This product will now 
be available for consideration for purchase under the President's Emergency 
Plan for AIDS Relief (PEPFAR).

Dr. Murray Lumpkin, the FDA Deputy Commissioner for International & Special 
Programs, said, "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 5 years, with a special focus on 15 of the hardest 
hit countries. The President's Plan is designed to prevent 7 mln new HIV 
infections, treat at least 2 mln HIV-infected people, and care for 10 mln 
HIV-affected individuals, AIDS orphans and vulnerable children. It targets 3 
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 & Research (CDER), has approved or 
tentatively approved over 12 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, Div of Antiviral 
Drug Products, and the FDA's Office of Regulatory Affairs, developed a focused, 
interactive approach to the product development and application review process. 
This is expected to resolve any issues that would delay the submission and 
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 that are now 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 US, it meets all of FDA's 
manufacturing quality and clinical safety and efficacy standards required for 
marketing in the US. 

As with all generic applications before granting approval or tentative 
approval, FDA conducts an onsite 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.

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