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Article: BRIEF: Endo: FDA needs time to review new use for pain med.
- Article from:
- The Philadelphia Inquirer (Philadelphia, PA)
- Article date:
- August 17, 2007
CopyrightCOPYRIGHT 2007 The Philadelphia Inquirer. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Byline: Linda Loyd
Aug. 17--Endo Pharmaceuticals Holdings Inc., Chadds Ford, said the U.S. Food and Drug Administration has asked for more time to review the company's application for a new indication of its migraine drug Frova.
Shares of Endo were up 39 cents, or 1.26 percent, to $31.23 in noon trading on the Nasdaq.
Analysts said while the FDA has postponed its decision indefinitely, Endo management indicated the agency simply needs more time and there were no current requests for additional data or safety concerns.
Frova was approved by the FDA in November 2001 to treat acute migraine headaches. Endo and its partner Vernalis Pls. ...