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
     "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."
     "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
     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.

SOURCE Schering-Plough Corporation

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.


PR Newswire Membership

Fill out a PR Newswire membership form or contact us at (888) 776-0942.

Learn about PR Newswire services

Request more information about PR Newswire products and services or call us at (888) 776-0942.