New product newswire: February 19, 2007
A new treatment is available for patients 12 years of age and older with psoriasis and eczema. Olux-E (clobetasol propionate) Foam, 0.05%, available in 50-and 100-gm canisters, is indicated for inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
NEW DRUGS
NOW AVAILABLE
From Pfizer Inc., Exubera (insulin human [rDNA origin]) Inhalation Powder is the first inhaled medication to help manage blood sugar. It can be used by itself in Type 2 diabetes, and it works with a long-acting injected insulin to treat Type 1 diabetes. Exubera has not been tested in patients under 18 years of age, and it should not be used in people who smoke or have smoked within six months of using the drug, as it can lower lung function. New York-based Pfizer can be reached at (212) 733-2323.
NEW LABELING
Boston Scientific Corp., Natick, Mass., (888) 272-1001, has the FDA's approval to extend the shelf life of its Taxus Express(2) paclitaxel-eluting coronary stent system to 18 months in the United States. The shelf life was previously set at 12 months. According to the company, the approval makes the Taxus stent's shelf life longer than that for competing products. Shelf life outside the United States remains at 18 months.
The FDA has approved revised labeling for Trasylol (aprotinin injection), from Bayer Pharmaceuticals, West Haven, Conn., (800) 468-0894. The drug is given to patients before heart surgery to reduce bleeding and the need for blood transfusions. The new labeling states that Trasylol should be given to patients who have an increased risk for blood loss and the possible need for blood transfusions while undergoing a cardiopulmonary bypass. The labeling also warns that Trasylol increases the risk for kidney damage, and it offers suggestions to reduce a patient's risk for sensitivity reactions.
NEW PACKAGING
Galderma Laboratories, Fort Worth, (817) 961-5000, is offering Clobex (clobetasol propionate) Spray, 0.05%, in a larger 4.25-fl.oz. bottle for the treatment of moderate to severe plaque psoriasis. The prescription product is already available in a 2-fl.oz. bottle. The product is administered twice daily. Clobex is not recommended for use by patients under the age of 18, and dosing should not exceed two fluid ounces per week.
NEW GENERICS
