KENILWORTH, N.J., Oct. 25 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today announced that Schering-Plough K.K., the company's country operation in Japan, has received marketing approval for CLARITIN(R) Dry Syrup 1% (loratadine drug syrup), a once-a-day nonsedating antihistamine for treatment of allergic rhinitis, urticaria and itching associated with skin diseases in patients ages 3 years and older. Additionally, CLARITIN(R) (loratadine) Tablets and CLARITIN(R) (loratadine) Reditab Tablets have been approved for these uses in patients over age 7 years.
"Allergies are a major health problem for many children," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering- Plough Research Institute. "CLARITIN Dry Syrup is an easily administered, long-lasting formulation for treating children as young as age 3, and approval of this new formulation provides an important treatment option for pediatric patients in Japan." Dry syrup is a unique granule formulation available only in Japan.
In Japan, Schering-Plough co-markets the CLARITIN line of medications with Shionogi & Co., Ltd. CLARITIN is marketed in over 100 countries worldwide and is available in several countries without a prescription. CLARITIN has been prescribed for more than 14 billion patient days since it was introduced in Belgium in 1988.
Allergic rhinitis, commonly referred to as "hay fever," is estimated to affect 15 million people in Japan. The market for prescription antihistamines in Japan is estimated to exceed $1 billion. Urticaria, a reaction to a variety of substances, including food, drugs and topical agents, and characterized by an eruption of itchy, swollen lesions on the skin, affects an estimated 15 to 25 percent of people at least once in their lives. Approximately 25 percent of urticaria patients develop chronic idiopathic urticaria (CIU), which is defined as a case that lasts for a period of at least six weeks and has no identifiable cause. More than 40 percent of prescription antihistamine use in Japan can be attributed to CIU and itching associated with skin diseases such as eczema.
CLARITIN tablets were approved by Japan's Ministry of Health, Labor and Welfare (MHLW) for patients 15 years of age and older in September 2002, and the Reditabs formulation was approved for patients 15 years and older in November 2004. The treatment's proven nonsedating efficacy has helped make CLARITIN a popularly prescribed antihistamine in Japan.
About CLARITIN(R)
CLARITIN was first approved for the treatment of symptoms of allergic rhinitis and CIU in Belgium in 1988. It was approved as a prescription product by the U.S. Food and Drug Administration (FDA) in 1993 and as an over-the- counter (OTC) medication in 2002.
About Schering-Plough
Schering-Plough K.K., based in Osaka, Japan, is the country operation of Schering-Plough Corporation, a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.
Schering-Plough disclosure notice: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential market for CLARITIN in Japan. Forward-looking statements relate to expectations or forecasts of future events. Schering- Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering- Plough's forward-looking statements, including market forces, economic factors, product availability, current and future branded, generic or over- the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 8.01 of the Company's 8-K filed on October 22, 2007.
CONTACT: Media Contact, Julie Lux, +1-908-298-4774; or Investor Contact,
Alex Kelly, +1-908-298-7436, both of Schering-Plough Corporation
Web site: http://www.schering-plough.com/
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