President's Emergency Plan for AIDS Relief

President's Emergency Plan for AIDS Relief
Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan
On September 3, 2009, FDA granted tentative approval for a generic fixed-does combination tablet containing efavirenz, lamivudine, and tenofovir disoproxil fumarate, 600mg/300mg/300mg. This new fixed-dose combination is manufactured by Matrix Laboratories Limited of Hyberdad, India. It is indicated for use alone or in combination with other antiretroviral products for the treatment of HIV-1 infection.
"Tentative approval" means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not presently eligible for final approval or marketing in the U.S. because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible for purchase outside the United States under the President’s Emergency Plan for AIDS Relief (PEPFAR).
As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility, and of the facilities performing the bioequivalence studies, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications.
A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan can be found on the FDA web site.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

In May 2004, in support of the President's Emergency Plan, FDA announced a new initiative to help ensure that those being served by the Presidents' Plan would receive safe, effective, and quality manufactured antiretroviral drugs. This new initiative included an expedited review process. Through guidance and an active outreach program to the pharmaceutical industry, FDA actively encouraged any sponsors worldwide to submit U.S. marketing applications for single entity, fixed dose combination (FDC), and co-packaged versions of previously approved antiretroviral therapies - even if there was still patent or exclusivity market protection for the product in the U.S.

FDA's special initiative for these products has involved four main components:

FDA reviews the marketing applications using its normal standards for authorization. If the product still has marketing protection in the U.S., FDA issues a "tentative approval" rather than a "full" approval. The "tentative" approval signifies that the product meets all safety, efficacy, and manufacturing quality standards for marketing in the U.S., and, but for the legal market protection, it would be on the U.S. market. USAID allows, under the President's Emergency Plan, purchase of any product that has either a "full" or "tentative" FDA approval. In this manner, the only products being offered under this program to the focus countries are products that we would offer our own citizens.
Very importantly, FDA works intensively with manufacturers who have not interacted with FDA previously to help them prepare an FDA application and to prepare for the requisite FDA inspections of their clinical trials and manufacturing facilities.
Due to the significant public health impact of these products, FDA prioritizes the review of these marketing submissions and has met its announced commitment to complete the reviews in as little as two to six weeks after submission of a high-quality application.
Finally, FDA has engaged proactively with its counterpart regulatory agencies in the President's Plan focus countries and with the WHO Pre-Qualification Unit to help them understand the initiative and the science that stands behind the regulatory decisions FDA is making so that they can more readily utilize the FDA efforts for local registration.

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President's Emergency Plan for AIDS Relief