If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Claritin Cleared by FDA for Urticaria MADISON, N.J., Sept. 25, 1995 -- Schering-Plough Corporation (NYSE: SGP) announced today that CLARITIN(R) (loratadine) 10mg Tablets has received marketing clearance from the U.S. Food and Drug Administration for a new indication -- idiopathic chronic urticaria -- commonly known as hives. Affecting one in five individuals at least once in their lives, this eruption of itchy, swollen welts can be triggered by any number of substances, ranging from foods, such as strawberries, to topical agents, like hair dye. Since its U.S. introduction in 1993, CLARITIN has become a market leader among antihistamines for relief from the symptoms of seasonal allergic rhinitis (hay fever), such as sneezing, runny nose, and itchy, watery eyes. "We're confident that this new indication for CLARITIN will further bolster its already strong position in the U.S. allergy market," said David M. Stout, president, Schering Laboratories, the U.S. prescription pharmaceutical marketing arm of Schering-Plough. In clinical trials, CLARITIN was found to be significantly more effective than placebo in relieving the symptoms of urticaria, including itching and swelling. "Although antihistamines have been the mainstay of urticaria treatment, until now they have either caused sedation or, in the case of other nonsedating antihistamines, may increase the risk of certain serious cardiovascular complications," said William Storms, M.D., associate clinical professor of medicine, University of Colorado Health Sciences Center. "CLARITIN is a welcome option for anyone who needs effective relief from hives," he added. CLARITIN does not contain a "black box" warning in its labeling. In clinical studies, using the recommended dose, the incidence of side effects associated with CLARITIN was low, similar to that found with placebo. They included headache, drowsiness, dry mouth and fatigue. CLARITIN, offering once-daily dosing, first received U.S. marketing clearance for seasonal allergic rhinitis (hay fever) in April 1993. CLARITIN-D, a twice-daily version with the decongestant pseudoephedrine, was granted U.S. marketing clearance in November 1994. The CLARITIN line of nonsedating antihistamines is marketed in 97 countries, including the United States. Schering-Plough manufactures and markets U.S. prescription pharmaceuticals through its Schering Laboratories, Key Pharmaceuticals and Warrick Pharmaceuticals units. Products include respiratory products, dermatologicals, anti-infectives, anticancer and antiviral products, and cardiovasculars. The company also manufactures and markets animal health products, leading over-the-counter (OTC) pharmaceuticals and personal care products. Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide. CONTACT: Steve Galpin, Jr. of Schering-Plough, 201-822-7415; or Barri Winiarski of Edelman Medical Communications, 212-704-8186
|
