Published in Law and Health Weekly, October 10th, 2009
Impax filed its Abbreviated New Drug Application ("ANDA") containing a paragraph IV certification for a generic version of ORACEA® with the U.S. Food & Drug Administration ("FDA"). Following receipt of the notice from the FDA that Impax's ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owners of its paragraph IV certification.
On September 18, 2009, The Research Foundation of State University of New...
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