The FDA approved an application by Bristol-Myers Squibb Co.to expand sales of Videx (ddI) to AIDS patients who hadpreviously taken the more widely prescribed AZT.
Videx was approved in 1991 for patients with advanced HIVwho are intolerant to AZT.
New studies have shown that patients who switched to Videxat 14 months did better than those who remained solely onAZT, though those studies did not provide any optimal timeperiod at which doctors should switch their patients to ddI.
Liz Sigler, spokesman for Bristol-Myers Squibb, said thecompany "expanded the labeling to include a broader patientpopulation last October with Phase I data. An FDA advisorypanel reviewed the preliminary results of the trial in April andapproved Monday the new drug application the company filedin June."
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