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FDA Approves Generic Formulation of Didanosine (ddI) Delayed Release Capsules

December 3, 2004

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

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 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.

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!



  
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This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
 
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