Tentative approval of generic didanosine for oral solution

The Food and Drug Administration, on October 5, 2006, granted tentative approval for didanosine for Oral Solution (Pediatric Powder), 10 mg/mL, manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India.

This is a generic version of the already-approved Videx Pediatric Powder for Oral Solution, 10 mg/mL, 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

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration