The U.S. Food and Drug Administration (FDA) today approved Celebrex (celecoxib) for a new use ? the relief of the signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) in patients two years of age and older. Today’s approval follows the November 29 meeting of FDA’s Arthritis Advisory Committee, in which the committee voted 15 to 1 in favor of approval of this product.
The Food and Drug Administration (FDA) today approved Cyanokit (containing the drug hydroxocobalamin, intravenous tubing and a sterile spike for reconstituting the drug product with saline) for the treatment of known or suspected cyanide poisoning. The approval, which is based on evidence of the drug’s effectiveness when tested in animals, improves the nation’s ability to respond to emergencies, including a potential attack by terrorists.
The U.S. Food and Drug Administration (FDA) is currently working with five states and the Centers for Disease Control and Prevention to investigate an outbreak of norovirus which has been associated with raw, frozen oysters on the half shell from South Korea.
The Society for Cardiovascular Angiography and Interventions (SCAI) has released recommendations for the prevention of contrast induced nephropathy (CIN) — potentially fatal kidney damage that can occur when a special dye is injected during certain cardiovascular procedures. The consensus document, the first to be written on this topic, appears in the January 2007 issue of Catheterization and Cardiovascular Interventions: Journal of the Society for Cardiovascular Angiography and Interventions.
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.
Many people with fibromyalgia — a debilitating pain syndrome that affects 2 to 4 percent of the population — have faced the question of whether the condition is real.Increasingly, though, the scientific knowledge about fibromyalgia is growing, and a new paper from the University of Michigan Health System says there are “overwhelming data” that the condition is real.
60 percent of Scottish doctors’ surgeries prescribe homeopathic remedies according to a study of nearly two million patients. Homeopathic prescribing is most prevalent among babies under 12 months and older people aged 81-90. The authors have called for a critical review of prescribing. The paper is published as leading UK scientific institutions voice concerns about changes to homeopathic labelling rules that came in in September 2006.
The Centre for Health Protection has confirmed an imported Dengue fever case involving a 27-year-old visitor, bringing the year’s total to 30, all imported.
The Centre for Health Protection has confirmed the year’s second leptospirosis case, involving a 35-year-old man who travelled to Macau before he developed symptoms.
Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that a single once-daily morning dose of the investigational amphetamine compound SPD465, extended release triple-bead mixed amphetamine salts, designed to reduce symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults for up to 16 hours, was bioequivalent to a dose of ADDERALL XR (mixed salts of a single-entity amphetamine product) followed by a dose of mixed amphetamine salts immediate release (“MAS IR”) eight hours later.