Bristol Videx Once-Daily Dosing Restricted After Unfavorable Trial Results
Executive Summary
Labeling for Bristol-Myers Squibb's Videx (didanosine) has been revised to recommend against once-daily dosing for most patients following negative findings from a clinical trial using the new 200 mg formulation of the drug.
You may also be interested in...
Videx EC Enteric-Coated Once-Daily Is Second Line To Videx Twice-Daily
Bristol-Myers Squibb's Videx EC enteric-coated, once-daily version of its nucleoside analogue is labeled as a second-line option to the original twice-daily formulations.
Videx EC Enteric-Coated Once-Daily Is Second Line To Videx Twice-Daily
Bristol-Myers Squibb's Videx EC enteric-coated, once-daily version of its nucleoside analogue is labeled as a second-line option to the original twice-daily formulations.
Bristol HIV franchises
Sales of nucleoside analogue Videx fell 27% to $19 mil. in the U.S. during the quarter as a "result of our repositioning Videx to be used in different therapy," Bristol Oncology & Immunology President Richard Winningham said. "Historically, Videx usage occurred quite a bit in combination with hydroxyurea. Beginning mid-to-late last year, we began to encourage physicians not to use Videx in combination with hydroxyurea and are positioning it with other regimens." Videx labeling was changed in October to warn of two fatalities in patients receiving Videx and hydroxyurea in ACTG 5025. Bristol received a warning letter from FDA for allegedly promoting the Videx/hydroxyurea combination despite the ACTG data (1"The Pink Sheet" Nov. 8, 1999, p. 29)