Cephalon, Inc. and Eurand NV today 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. 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).
The details can be read here.
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