FDA clears Nasalcrom for over-the-counter sale.WASHINGTON--(BUSINESS WIRE)--January 6, 1997-- The First Medication Indicated for Prevention and Treatment of Nasal Allergies without Drowsiness The U.S. Food and 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. ) today cleared Nasalcrom(R) (cromolyn sodium) for over-the-counter (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). ) marketing. Nasalcrom is the first OTC allergy treatment indicated for prevention as well as treatment of symptoms of allergic rhinitis and will be marketed in the U.S. by McNeil Consumer Products, a Johnson & Johnson company. Nasalcrom is due in stores in time for the spring allergy season. Forty million Americans -- one out of six -- suffer from misery-inducing allergic rhinitis, which can produce an itchy, runny nose, and congestion The condition of a network when there is not enough bandwidth to support the current traffic load. congestion - When the offered load of a data communication path exceeds the capacity. and sneezing. Well over ten million sufferers are children, who miss an estimated two million days of school as a result of their nasal allergies. Allergic rhinitis costs Americans an estimated $4 billion each year and can lead to associated illnesses, including otitis media (middle ear infection middle ear infection Otitis media ENT A condition characterized by inflammation, fluid overproduction–which may rupture the tympanic membrane, providing a portal of entry for bacteria and viruses, purulence, bleeding; MEI is more common in children as their ), asthma attacks and sinusitis sinusitis Inflammation of the sinuses. Acute sinusitis, usually due to infections such as the common cold, causes localized pain and tenderness, nasal obstruction and discharge, and malaise. . Nasalcrom 4% Nasal Solution was cleared by the FDA for marketing as a prescription drug in 1983. It was developed by Fisons Corp., is marketed as a prescription product by Rhone Poulenc Rorer and is licensed to McNeil Consumer Products Company for OTC marketing in the U.S. Since its approval, more than 17 million prescriptions have been written for Nasalcrom in the U.S. alone. Prescription Nasalcrom will be available in the United States only until the over-the-counter version is introduced. Nasalcrom's FDA clearance follows an October recommendation by FDA's Nonprescription non·pre·scrip·tion adj. Sold legally without a physician's prescription; over-the-counter. and Pulmonary Allergy Drug Advisory Committees based in part on a double-blind, multi-center use study of 1138 subjects comparing Nasalcrom to a placebo. The OTC effectiveness and safety of Nasalcrom were demonstrated in this study. The Domino Effect of Allergies Allergic reactions to substances such as pollen and ragweed ragweed, any plant of the genus Ambrosia, coarse, weedy herbs belonging to the family Asteraceae (aster family), most of which are native to America. They have inconspicuous greenish flowers and soft subdivided leaves. (allergens) occur when the foreign substance enters the nose. Antibodies to the allergens are released, which bind with mast cells, sensitizing sen·si·tize v. sen·si·tized, sen·si·tiz·ing, sen·si·tiz·es v.tr. 1. To make sensitive: "The polarity principle . . . the body to future exposure to the allergen. Subsequent contact with the offender is recognized by the mast cells, causing the cells to break down and release histamine and other inflammatory mediators. The result is increased mucous production, congestion, runny nose and swelling. Nasalcrom works differently than antihistamines Antihistamines Definition Antihistamines are drugs that block the action of histamine (a compound released in allergic inflammatory reactions) at the H1 , which inhibit the uptake of histamine, and inhaled corticosteroids, which inhibit certain inflammatory processes. With regular use, Nasalcrom also suppresses inflammatory cell activity. Moreover, it stabilizes the mast cells in the nose, dampening the domino effect of an allergic reaction. To prevent nasal allergy symptoms, regular use of Nasalcrom should start one week prior to contact with the offending allergen and should continue everyday while in contact with the offending allergen. Excellent Safety Profile The various nasal allergy medications currently available OTC may not provide adequate relief or may have limiting side effects which inhibit their use by some allergy sufferers. Nasalcrom has an outstanding safety profile, according to Peter S. Creticos, MD, medical director at the Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C. Asthma and Allergy Center. It does not cause the drowsiness that has been associated with antihistamines or the "rebound effect" linked to OTC topical nasal decongestants, which can lead to increased congestion after three days of use. Moreover, decongestants Decongestants Definition Decongestants are medicines used to relieve nasal congestion (stuffy nose). Purpose A congested or stuffy nose is a common symptom of colds and allergies. carry labels warning against use in patients with high blood pressure, heart disease, diabetes and other conditions. Extensive use has shown that Nasalcrom can be used safely in patients who suffer from these conditions. A brief nasal stinging or sneezing may occur immediately following use of Nasalcrom. Only about 7 percent of Nasalcrom is absorbed into the blood stream and it is not metabolized in the body. Cromolyn sodium nasal solution is registered in more than 80 countries around the globe, and is available without a prescription in more than a dozen of those. -0- An electronic product image is available. For instructions on how to download the image, or for a black and white photograph, call (202) 835-9482. CONTACT: McNeil Consumer Products Company Ron Schmid, 215/233-8146 |
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