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Article: Adolor Gets Entereg Approvable Letter, But More Data Required.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. 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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Washington Editor
An approvable letter caused quite a swing in Adolor Corp.'s stock Friday.
Before the bell rang, the company's shares (NASDAQ:ADLR) were down more than 10 percent in premarket trading, but by the end of the day, the stock had swung back into the black and gained 22 cents to close at $10.48.
The market volatility followed the FDA's communication on a marketing application for Entereg (alvimopan), under review for the management of postoperative ileus by acceleration of the time to recovery of gastrointestinal (GI) function following bowel-resection surgery.
"We intend to request a meeting with the FDA as soon as ...