Perrigo Sues FDA For Failing To Publish Approval Of Gel
By Brian Mahoney (March 24, 2014, 2:20 PM EDT) -- Perrigo Israel Pharmaceuticals Ltd. on Friday sued the U.S. Food and Drug Administration in D.C. federal court, alleging the agency has failed to update its records to reflect its approval of Perrigo's testosterone gel product.
The company sued to redress the agency's alleged failure to timely update its so-called Approved Drug Products with Therapeutic Equivalence Evaluations — also known as the Orange Book — to add a therapeutic equivalence rating for the testosterone gel, which is a generic version of AbbVie's AndroGel.
The alleged failure "continues to cause actual and imminent harm to Perrigo," the complaint said.
The FDA approved the...
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