HHS Food and Drug Administration Gives Tentative Approval to First Generic Version of Tenofovir

December 1, 2007 – On November 30, 2007, the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS) granted tentative approval for a generic version of Tenofovir Disoproxil Fumarate tablets, 300 milligrams, manufactured by Matrix Laboratories Limited, of Hyderabad, India. The application came under the expedited review provision established as part of the President's Emergency Plan for AIDS Relief, under which products must meet the same standards required for drugs used in the United States. Tentative approval by HHS/FDA fully qualifies this product for purchase by the Emergency Plan, although patent protections or other market exclusivities prevent it from being sold yet in the United States. This is the 56th generic drug to receive HHS/FDA tentative approval.

The use of Tenofovir as one of a first-line or a second-line antiretroviral combination therapy is increasing rapidly among Emergency Plan partners. This is the first HHS/FDA tentative approval for Tenofovir, and the availability of a generic version of Tenofovir should have a positive impact on both price and access to this important drug. Appropriate product registration or an approved importation waiver by the national drug regulatory authority in Emergency Plan focus countries will be required before the product reaches patients.

For more information:

• Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan for AIDS Relief (U.S. Food and Drug Administration)

Last revised: December 11, 2007