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Patents
Cephalon and Eurand Announce Notification of Generic Filing for Cyclobenzaprine Hydrochloride Extended-Release Capsules
November 9th, 2008
Cephalon, Inc. (NASDAQ:CEPH) and Eurand NV (NASDAQ:EURX) announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2008 regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Mylan Pharmaceuticals, Inc., requesting approval to market and sell a generic version of the 15 mg and 30 mg strengths of AMRIX(R) (Cyclobenzaprine Hydrochloride Extended-Release Capsules). In the Notice Letter, Mylan alleges that the U.S. Patent Number 7,387,793, entitled "Modified Release Dosage Forms of Skeletal Muscle Relaxants," issued to Eurand is invalid, unenforceable and/or will not be infringed by Mylan's manufacture, use or sale...
Source: Medical Letter on the CDC & FDA (2008-11-09)
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