Impax Laboratories, Inc. (NASDAQ:IPXL) confirms that it has initiated a challenge of patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL® (Colesevelam HCl) tablets, 625 mg. Impax filed its Abbreviated New Drug Application ("ANDA") containing a paragraph IV certification for a generic version of WELCHOL® 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...
More...
More...