FDA approves Tavist products as effective for relief of cold symptoms.EAST HANOVER, N.J.--(HealthWire)--Nov. 7, 1996--The Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has approved Tavist-D(R) and Tavist-1(R) as proven effective in relieving cold symptoms. The FDA decision results from well-controlled clinical studies of the antihistamine antihistamine (ăn'tĭhĭs`təmēn), any one of a group of compounds having various chemical structures and characterized by the ability to antagonize the effects of histamine. clemastine fumarate clem·a·stine fumarate n. An antihistamine used primarily to treat allergic rhinitis and allergic skin disorders. clemastine fumarate (klem´ , the active ingredient that differentiates the Tavist products from others. "The FDA's decision is especially significant because the studies conducted on all other antihistamines Antihistamines Definition Antihistamines are drugs that block the action of histamine (a compound released in allergic inflammatory reactions) at the H1 to support cold symptom effectiveness so far have been judged inconclusive by the FDA," said Mark Gelbert Ph.D., Executive Director of Scientific Affairs for Sandoz Pharmaceuticals Corp. Consumers may easily become confused when shopping for cold medications because of the overwhelming selection from which to choose. However, at this time, claims marketed on a product's packaging aren't necessarily a result of adequate clinical studies accepted by the FDA. "With its decision, the FDA has accepted our research proving Tavist's effectiveness," said Gelbert. "While we know that many consumers already take Tavist for cold symptoms, the approval allows the product to now incorporate this claim on its new labeling." After reviewing the findings of two well-controlled clinical studies plus several supporting studies, in November 1995 an FDA Advisory Panel unanimously recommended that the Tavist products, with the antihistamine clemastine fumarate, be recognized by the FDA as effective in treating cold symptoms, including sneezing To verbally tell somebody about a new and interesting Web site. See viral marketing. and runny nose runny nose Vox populi → medtalk Rhinorrhea . Tavist-1 and Tavist-D, which were introduced as over-the-counter medications in full prescription strength in 1992, have long been used by millions of Americans for relief from sinus and allergy symptoms. Sandoz Pharmaceuticals Corp. is engaged in the research, manufacturing and marketing of prescription and over-the-counter pharmaceutical products, including Triaminic, TheraFlu and Gas-X. Sandoz is also a world leader in prescription drugs for the treatment of organ transplants, mental health, aging, headache and other types of pain and hypertension. CONTACT: Publicis Public Relations public relations, activities and policies used to create public interest in a person, idea, product, institution, or business establishment. By its nature, public relations is devoted to serving particular interests by presenting them to the public in the most Dana Manley/Ann Pask, 214/443-9901, ext. 5426/5493 |
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