Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
Food and Drug Administration - October 6, 2006
Richard Klein & Kimberly Struble
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
061006
FD061001
SOURCE: Food and Drug Administration (FDA).
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