Food and Drug Administration - September 25, 2008
Richard Klein & Kimberly Struble

On September 24, 2008, FDA approved a generic formulation of Didanosine (ddI) Delayed Release Capsules, 125 mg, 200 mg, 250 mg, and 400 mg, manufactured by Aurobindo Pharma Limited, Hyberdad, India. Didanosine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI), which helps keep HIV, the virus that causes AIDS, from reproducing, and is intended to be used with other anti-retroviral agents for the treatment of HIV-1 infection.

The application was reviewed under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR). Approval of the generic formulation means that there are no existing patents and/or exclusivities preventing marketing of this product in the United States, and qualifies it for purchase under the PEPFAR program outside the U.S.

This is a generic version of Videx EC, made by Bristol Myers Squibb Co.

As with all FDA-approved generics, this product must meet all of FDA's manufacturing quality, and clinical safety and effectiveness standards for U.S. marketing.

A list of approved and tentatively approved antiretrovirals associated with PEPFAR can be found at:
http://www.fda.gov/oia/pepfar.htm.

A list of approved generic drugs used in the treatment of HIV infection will be found at:
http://www.fda.gov/oashi/aids/viralsgeneric.html

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

080925
FD080906

SOURCE: Food and Drug Administration (FDA).

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