King Pharmaceuticals Reports FDA Approval of Two Products as Bioequivalent for Levoxyl

King Pharmaceuticals, Inc. reported that the Food and Drug Administration (FDA) has approved supplemental New Drug Applications (sNDA) which provide that Unithroid (levothyroxine sodium tablets, USP) and Levo-T® (levothyroxine sodium tablets, USP) are bioequivalent and therapeutically equivalent to Levoxyl (levothyroxine sodium tablets, USP).

Despite the Company's expectation to the contrary, the FDA granted these approvals without requiring certification against King's patent number 6,555,581 ("the '581 Patent") which pertains to Levoxyl® and is listed in the FDA's publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the "Orange Book". King is currently evaluating the appropriateness of such approvals and considering potential legal recourse.