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Tentative approval for didanosine chewable tablets

The Food and Drug Administration, on July 10, 2006, granted tentative approval for didanosine tablets (chewable, dispersible, buffered), 100 mg, 150 mg and 200 mg, manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India.

This is a generic version of the already-approved Videx Chewable Tablets manufactured by Bristol Myers Squibb.

The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR).

"Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, though it may not yet be marketed in the U.S. because of existing patents and/or exclusivity rights. Tentative approval, however, does make the product eligible for consideration for purchase under the PEPFAR program.

Didanosine is a member of the class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This antiretroviral drug is intended to be used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Page Last Updated: 08/05/2014
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