FDA approves generic formulation of didanosine (ddI) delayed release capsules
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Accession Number
A00726
Author
US Department of Health and Human Services (HHS), Food and Drug Administration (FDA)
Source
FDA List Serv Announcement
Release Date
December 3, 2004
Major Descriptors
FDA approval
Topic
Text
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
FDA Listserv Announcement 12/3/2004.
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