Published in Medical Verdicts and Law Weekly, April 2nd, 2009
Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of RENAGEL® 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 owner of its paragraph IV certification.
On March 13, 2009, Genzyme filed suit for patent infringement against Impax...
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