Healthcare Industry News:  King Pharmaceuticals 

Biopharmaceuticals FDA

 News Release - December 4, 2006

King Pharmaceuticals Reports FDA Approval of New Skelaxin(R) Label

BRISTOL, Tenn.--(HSMN NewsFeed)--King Pharmaceuticals (NYSE: KG ) reported today that the U.S. Food and Drug Administration ("FDA") has approved the Company's revised prescribing information for its Skelaxin® (metaxalone) product. Skelaxin® is a leading branded muscle relaxant, indicated as an adjunct therapy for the relief of discomforts associated with acute, painful musculoskeletal conditions. The new labeling includes revised "Precautions" and "Clinical Pharmacology: Pharmacokinetics" sections.

The new Skelaxin® label is available on the internet at http://www.skelaxin.com/skelaxin/insert.asp.

About Skelaxin®

SKELAXIN® is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man. The most frequent reactions to metaxalone include nausea, vomiting, gastrointestinal upset, drowsiness, dizziness, headache, and nervousness or "irritability."

About King Pharmaceuticals

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

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