Novartis' Gleevec Gets FDA OK
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Posted by Dow Jones Business News on May 20, 2003 at 12:25:36:
Tuesday May 20, 2:35 pm ET EAST HANNOVER, N.J. -(Dow Jones)- Novartis Pharmaceuticals Corp.'s Gleevec drug obtained accelerated Food and Drug Administration (News - Websites) approval for treating a rare form of leukemia in children. In a press release Tuesday, Novartis said the approval was based on extrapolation from results among adult patients, as well as a small number of children. Subsequent studies after approval will be conducted to confirm the drug has clinical benefit for pediatric patients, Novartis said. The drug was originally granted accelerated approval two years ago for certain kinds of leukemia in adults. In February, Gleevec was also granted accelerated approval for treating adult gastrointestinal stromal cancer. In its first full year on the market, 2002 Gleevec sales were $615 million out of total Novartis sales of $1.8 billion. -John Seward; Dow Jones Newswires; 201-938-5400
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