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Article: Anticipated Generic ACTIQ Filing Occurs; Cephalon Expects No Change in Barr's Likely Date of Market Entry.
- Article from:
- PR Newswire
- Article date:
- December 8, 2004
CopyrightCOPYRIGHT 2004 PR Newswire Association LLC. 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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Cephalon, Inc. today learned that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of an abbreviated new drug application (ANDA) filed with a paragraph IV certification by Barr Laboratories, Inc. for a generic form of ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II].
In connection with Federal Trade Commission clearance of its acquisition of CIMA LABS INC., Cephalon granted a license to Barr covering any remaining intellectual property related to ACTIQ. The license agreement contemplates that Barr would file and gain approval for its own ANDA to market a generic version of ACTIQ. However, Barr can only obtain the 180-day statutory ...