FDA: Cephalon's Nuvigil needs warning |
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Fri, 30 Mar 2007 23:07
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FRAZER, Pa. (AP) - Drug developer Cephalon Inc. said Friday its narcolepsy drug candidate Nuvigil will be approved by the Food and Drug Administration, but must carry labeling warning of skin rash and hypersensitivity.The FDA, which issued an 'approvable letter,' also requested a standard safety update from clinical trials conducted since the last update in June and introductory promotional materials. Such a letter means the drug will be approved once certain requirements have been met.In addition, the agency gave Cephalon draft labeling for the drug and its similar Provigil treatment that includes a proposed bold warning for skin rash and hypersensitivity.'While we fully appreciate that this regulatory review has been difficult and lengthy for stockholders and others interested in the outcome, we are convinced that in this unusual situation where multiple products may be affected, the final result will prove to be worth the investment of time and effort,' said Frank Baldino Jr., chairman and chief executive.The company will respond to the information request within 30 days and the FDA is expect to complete its review within 60 days of receiving the response.Shares of Cephalon fell 46 cents to close at $71.21 on the Nasdaq Stock Market, but rose $1.19 to $72.40 in aftermarket trading.Copyright 2007 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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