Schering-Plough Announces Prescription-Strength CLARITIN(R) Approved For Over-The-Counter Sales
Nation's Most-Prescribed Antihistamine To Be
Widely Available Without a Doctor's Prescription for Allergies
Only OTC Antihistamine to Provide Once-daily Non-drowsy Allergy Relief
KENILWORTH, N.J., Nov. 27 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) announced today that all five formulations of the CLARITIN(R) brand of non-drowsy allergy products have been approved at their original prescription strengths by the U.S. Food and Drug Administration (FDA) as over-the-counter (OTC) medicines for the treatment of allergies. With this approval, the CLARITIN brand becomes the only OTC antihistamine to offer non-drowsy allergy relief to adults and children 2 years of age and older. The company expects that CLARITIN OTC products will be available by mid-December to consumers across the nation where OTC medicines are sold. The approval of CLARITIN as the only non-drowsy OTC antihistamine for allergies builds upon Schering-Plough's more than 50-year heritage as a leader in the discovery, development and marketing of allergy medications. With this approval, Schering-Plough now offers a full range of non-drowsy prescription and OTC treatment options for allergy sufferers, including prescription CLARINEX(R) (desloratadine), the first and only 24-hour nonsedating prescription antihistamine approved for the treatment of allergies caused by year-round indoor allergens and seasonal outdoor allergens, and prescription NASONEX(R)(mometasone furoate monohydrate), a once-daily nasal-inhaled steroid. "The availability of CLARITIN as a non-drowsy, original prescription-strength OTC antihistamine represents an important new treatment option for the estimated 20 million Americans who currently choose to treat their allergies with a non-prescription medication," said Richard W. Zahn, president of Schering Laboratories, the U.S. pharmaceutical and OTC marketing arm of Schering-Plough. "The conversion of CLARITIN to OTC status, together with the continued strength of prescription CLARINEX, gives Schering-Plough an opportunity to establish leadership in both the prescription and OTC antihistamine categories by providing allergy sufferers with treatment options that offer non-drowsy relief - with or without a doctor's prescription." A MILESTONE IN OTC ALLERGY RELIEF "The approval of CLARITIN as an OTC product at its original prescription strength is a milestone in allergy relief for millions of light-to-moderate allergy sufferers who choose OTC antihistamines," said Leonard Fromer, M.D., board certified in family practice, with a practice subspecialty in allergy, at the Prairie Medical Group in Santa Monica, Calif., and a Fellow of the American Academy of Family Physicians. "As a doctor, I believe CLARITIN is an important addition to the non-prescription allergy category because it is currently the only OTC antihistamine that effectively controls allergy symptoms without sedating side effects." "Currently available OTC antihistamines must carry warnings about drowsiness and performing tasks requiring mental alertness," said Gary Kay, Ph.D., clinical associate professor of neurology at Georgetown University. "CLARITIN controls allergy symptoms without causing drowsiness giving allergy sufferers the freedom to go about their normal daily activities. The availability of CLARITIN as an OTC product is good news for the many allergy sufferers who currently choose not to treat their symptoms with OTC products due to concerns about sedating side effects, which may impair performance," added Kay. The CLARITIN line of OTC products will be marketed in all of its five formulations, each at its original prescription strength. The CLARITIN line of products includes: CLARITIN(R) Tablets, a once-daily formulation; CLARITIN(R) RediTabs Tablets, a novel once-daily formulation in an orally disintegrating tablet; CLARITIN-D(R) 24 Hour Extended Release Tablets, a once-daily formulation with a decongestant; CLARITIN-D(R) 12 Hour Extended Release Tablets, a twice-daily formulation with a decongestant; and CLARITIN(R) Syrup, a liquid formulation for use in children 2 years of age and older. The company intends to support CLARITIN as an OTC product with a multi-faceted educational program focusing on allergies, allergy management and potentially associated conditions, such as asthma. The program will also provide allergy sufferers with recommendations about when to remain in close communication with their treating physician. Allergies affect an estimated 50 million people in the United States and can have a significant impact on daily activities at work, school and leisure time. The direct costs of seasonal allergies, including medications and physician visits, have been estimated at $4.5 billion annually. Indirect costs from absenteeism include the loss of an estimated 6 million workdays and 2 million school days each year. It is estimated that 77 percent of Americans with allergies use some form of medication to treat their allergy symptoms. For people who recognize and understand their allergy symptoms, CLARITIN offers a safe and effective, once-daily alternative to currently available OTC antihistamines - all of which have sedating side effects. The company also announced that it received an "approvable" letter from the FDA for the use of CLARITIN as an OTC treatment for hives. To obtain approval, the FDA has asked the company for the following: - Provide the results of a label comprehension study or studies that demonstrate consumers are able to understand how to safely use these drugs to treat hives. The label studied should be consistent with 21 CFR 201.66 and include language identifying the OTC indication as "hives," as recommended by the Nonprescription Drugs Advisory Committee. - Provide labeling to all three supplements that is supported by the results of the label comprehension study or studies. As a prescription product, CLARITIN was indicated for chronic idiopathic urticaria, which represented about 2 percent of CLARITIN line prescriptions. DISCLOSURE NOTICE: The information in this press release includes certain forward-looking statements concerning the market potential for CLARINEX and OTC CLARITIN. The reader of this press release should understand that the extent to which CLARINEX will be prescribed and OTC versions of CLARITIN will be used will be determined by market forces and are subject to substantial risks and uncertainties. The reader of this press release should also understand that, as the company has previously disclosed in various filings and press releases, either the introduction of generic prescription or OTC loratadine or OTC CLARITIN in the U.S. market would likely have a rapid, sharp and material adverse effect on the company's results of operations. Further, the reader of this release should understand that the forward-looking statements may also be adversely affected by general market and economic factors, competitive product development, market acceptance of new products, product availability, current and future branded, generic or OTC competition, federal and state regulations and legislation, the regulatory process for new products and indications, existing and new manufacturing issues that may arise, trade buying patterns, patent positions, litigation and investigations, and the elimination of trade inventories in a manner different than the company expected. For further details and a discussion of these and other risks and uncertainties, see the company's Securities and Exchange Commission filings, including the company's 2001 annual report on Form 10-K and subsequent quarterly reports on Form 10-Q and current reports on Form 8-K. Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and consumer health care products worldwide.RELATED LINKS
SOURCE Schering-Plough Corporation
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