King Pharmaceuticals Reports FDA Approval of New Skelaxin Label
BRISTOL, Tenn., December 4, 2006 -- King Pharmaceuticals 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.
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."
Posted: December 2006