Pfizer gets FDA approvable letter |
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Published
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Wed, 20 Jun 2007 23:05
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NEW YORK (AP) - Drug developer Pfizer Inc. said Wednesday the Food and Drug Administration sent the company an approvable letter for its HIV treatment candidate maraviroc, which is under regulatory review.An approvable letter is a request for more information, sometimes necessitating a new clinical trial. Pfizer did not say what information the FDA requested in its approvable letter.The drug candidate is aimed at treating patients infected with CCR5-tropic HIV-1 who have become resistant to one or more currently available treatments.More than 2,000 patients worldwide have received the drug candidate through clinical trials, Pfizer said.Shares of Pfizer fell 50 cents to $25.71 Wednesday.------------Questions or comments about this story should be directed to Damian J. Troise at 212-621-7190Copyright 2007 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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Shire stimulant SPD465 gets FDA approvable letter; evaluating options 