AEGiS-FDA: Approval of Generic ddI Food and Drug AdministrationImportant note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
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Approval of Generic ddI

Food and Drug Administration - December 3, 2004
Richard Klein, Kimberly Struble

The Food and Drug Administration (FDA) today (December 3, 2004) approved a generic formulation of Didanosine (ddI) Delayed Release capsules, 200 mg, 250 mg, and 400 mg for use in combination with other antiretroviral agents in the treatment of HIV-1 infection in adults. The product, manufactured by Barr Laboratories, Inc. of Pomona, NY will be available for use within the United States and foreign countries.

It is the first approval in the United States of a generic antiretroviral product to treat HIV/AIDS.

Didanosine (ddI) is the a generic version of the already approved Videx EC Delayed-Release Capsules manufactured by Bristol Myers Squibb. It is a delayed-release capsule, taken once daily.

Richard Klein Office of Special Health Issues Food and Drug Administration

Kimberly Struble Division of Antiviral Drug Products Food and Drug Administration
041203
FD041202

SOURCE: Food and Drug Administration (FDA).

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