Biotechnology Business
Cephalon Notified of Generic Fentanyl Buccal Tablet Filing
Published in Drug Law Weekly, May 6th, 2008
Cephalon, Inc., (NASDAQ:CEPH) announced its receipt of a Paragraph IV Certification Notice Letter relating to an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Watson Laboratories, Inc., requesting approval to market and sell a generic version of FENTORA(R) (fentanyl buccal tablet) [C-II]. In its Notice Letter, Watson alleges that the U.S. Patent Numbers 6,200,604 and 6,974,590 covering FENTORA are invalid, unenforceable and/or will not be infringed by Watson's manufacture, use or sale of the product described in its ANDA.
Cephalon currently is reviewing the Notice Letter and, by statute, has 45 days to initiate a...
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Source: Drug Law Weekly (2008-05-06)
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