Important note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.
United Press International - October 6, 2009
The approval, officials said, came under the President's Emergency Plan for AIDS Relief, a program aimed at the prevention, treatment and care of people infected with HIV/AIDS.
"This milestone exemplifies the dedication, caring and hard work of all who strive to better the lives of those infected with or affected by HIV/AIDS," said HHS Secretary Kathleen Sebelius.
Of the 100 products that have been fully or tentatively approved by the U.S. Food and Drug Administration -- part of HHS -- 29 have been new products and 71 have been generic copies of previously authorized antiretroviral products in the United States, officials said. Twenty-two of the new products are new combinations or regimens that have not previously been authorized in the United States. There are also seven new pediatric products considered innovative for patients in developing economies.
FDA officials said drugs used in the program receive "tentative approval" and cannot be approved for marketing in the United States because of existing patents and marketing exclusivity. However, the products meet all the FDA's manufacturing quality, clinical safety and efficacy requirements to produce them using the same standards as required for marketing in the United States.
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