BRISTOL, Tenn., June 24 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) reported today that the Food and Drug Administration ("FDA")
has approved supplemental New Drug Applications (sNDA) which provide that
Unithroid(R) (levothyroxine sodium tablets, USP) and Levo-T(R) (levothyroxine
sodium tablets, USP) are bioequivalent and therapeutically equivalent to
Levoxyl(R) (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(R) 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.
Brian A. Markison, acting President and Chief Executive Officer of King,
noted, "The American Thyroid Association (ATA), The Endocrine Society (TES),
and the American Association of Clinical Endocrinologists (AACE) issued a
joint release today regarding their concerns with respect to the methodology
used by the FDA to determine bioequivalence. In their release these
organizations indicate that there is the potential for health issues that may
arise from this action which is of great concern to our Company, healthcare
professionals, and ultimately patients who utilize levothyroxine sodium
products." A copy of the joint release issued by the ATA, TES, and AACE may be
found at http://www.thyroid.org/professionals/advocacy/04_06_24_fda.html.
King also reported today the receipt of the FDA's denial of the Company's
Citizen Petition challenging the appropriateness of the FDA's bioequivalence
methodology for levothyroxine sodium tablets.
The '581 Patent is a utility patent that covers the Company's novel
Levoxyl(R) product. The '581 Patent extends through February 15, 2022.
King, headquartered in Bristol, Tennessee, is a vertically integrated
branded pharmaceutical company. King, an S&P 500 Index company, seeks to
capitalize on opportunities in the pharmaceutical industry through the
development, including through in-licensing arrangements and acquisitions, of
novel branded prescription pharmaceutical products in attractive markets and
the strategic acquisition of branded products that can benefit from focused
promotion and marketing and product life-cycle management.
SOURCE King Pharmaceuticals, Inc.
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Related links:
http://www.kingpharm.com
Company News On-Call:
http://www.prnewswire.com/comp/120319.html
CONTACT:
James E. Green, Executive Vice President,
Corporate Affairs, King Pharmaceuticals, Inc., +1-423-989-8125
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