FDA Approves Labeling Change For Non-Drowsy CLARITIN(R)

Main Category: Allergy
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 23 Jan 2008 - 0:00 PDT

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Schering-Plough (NYSE: SGP) announced that the U.S. Food and Drug Administration has approved additional labeling for CLARITIN(R) (loratadine), which clearly tells consumers that the non-drowsy over-the-counter medication relieves allergy symptoms caused by both indoor (also called perennial or year-round) and outdoor (also called seasonal) allergies.

"Schering-Plough is pleased that the FDA has approved the change to the CLARITIN label to help us to communicate to consumers that CLARITIN works hard to relieve both indoor and outdoor allergies," said John E. O'Mullane, BSc, PhD, Group Vice-President, Research and Development, Schering-Plough Consumer Health Care.

Common indoor allergens include mold, dust mites, and pet dander, while common outdoor allergens include grass, tree, and ragweed pollen. Though they stem from different sources, indoor and outdoor allergies have the same pathophysiology, meaning they affect the body in the same way. Symptoms of both types of allergies include runny nose; sneezing; itchy, watery eyes; and itching of the nose or throat.

"People often associate allergies with outdoor triggers like pollen and grass, but many people's allergies are actually caused by things found in their home, office, or school," said Marjorie Slankard, M.D., allergist and clinical professor of medicine at the Columbia University College of Physicians and Surgeons. "When choosing an allergy medication, it's important to recognize that not all treatments are the same. Many patients and providers prefer a non-drowsy antihistamine, such as CLARITIN, because of its proven record in relieving symptoms of indoor and outdoor allergies." CLARITIN is the only brand proven to keep allergy sufferers as alert and focused as someone without allergies.* Allergy sufferers who are unsure about which treatment option is right for them should talk to their doctors.

CLARITIN is approved as effective against indoor (perennial) allergies in 110 countries worldwide.

Only brand clinically tested.

About CLARITIN

All CLARITIN brand products are available without a prescription, including: CLARITIN Tablets, a once-daily full prescription strength, non- drowsy formulation; CLARITIN RediTabs(R) Tablets, a novel once-daily formulation in a quickly dissolving tablet for ages 6 and older; CLARITIN-D(R) 24-hour and 12-hour Extended Release Tablets, with the decongestant pseudoephedrine now located behind the counter; CHILDREN'S CLARITIN(R) Syrup, a liquid formulation for children ages 2 and older in grape and fruit flavors; CHILDREN'S CLARITIN(R) Grape Chewables, a chewable tablet for children ages 2 and older; and CLARITIN Hives Relief(TM) tablets.

CLARITIN is the No. 1 physician-recommended and pediatrician-recommended over-the-counter antihistamine brand for allergic rhinitis. The CLARITIN Rx- to-OTC switch in 2002 was the largest switch ever-and the first and only for a non-sedating antihistamine. For more information on allergies and treatment, visit http://www.CLARITIN.com.

About Schering-Plough

Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company's ongoing transformation. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

Schering-Plough
http://www.schering-plough.com