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New Rx New Generics
Five new indications have been granted to Pfizer Inc. for Lipitor (atorvastatin). Lipitor is now the first cholesterol-lowering medication approved for reducing the risk of hospitalization for heart failure, and is indicated also to reduce the risk of nonfatal heart attacks, fatal and nonfatal strokes, certain types of heart surgery, and chest pain in patients with heart disease. Lipitor was already approved to reduce cardiovascular events in patients without heart disease. Pfizer, headquartered in New York City, can be reached at (212) 733-2323.
Humira (adalimumab), from Abbott Laboratories, Abbott Park, Ill., (800) 255-5162, has an additional indication: to reduce the signs and symptoms of, and induce and maintain clinical remission in, adults with moderately to severely active Crohn's disease refractory to conventional therapy. Humira was already approved to treat rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis and to inhibit the progress of joint damage.
Eli Lilly & Co., Indianapolis, (800) 545-5979, has been given approval for the use of Cymbalta (duloxetine HCl) in the treatment of generalized anxiety disorder. Cymbalta, a serotonin and norepinephrine reuptake inhibitor, is already approved for treating major depressive disorder and the management of diabetic peripheral neuropathic pain.
The FDA has approved a new tablet formulation for Altace (ramipril) for King Pharmaceuticals, Bristol, Tenn. The ACE inhibitor was previously available in capsule form and is used for the treatment of hypertension. King can be reached at (423) 989-2000.
NEW DOSAGE STRENGTHS
Alpharma Inc., Fort Lee, N.J., (201) 947-7774, is introducing a 200-mg capsule for Kadian (extended-release morphine sulfate). Kadian was approved earlier-in strengths of 20, 30, 50, 60, 80, and 100 mg-for the management of moderate to severe chronic pain where treatment with an opioid analgesic is indicated for more than a few days.
From Auriga Laboratories, Norcross, Ga., (877) 287-4428, prescription-only Aquoral helps soothe and heal the symptoms of xerostomia, or dry mouth. Its formulation is based on oxidized glycerol triesters, an oxygen-enriched plant derivative. Auriga acquired the Aquoral license from Laboratoire Carilène, a French therapeutics developer.