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Loratadine/Montelukast Combo Accepted for FDA Filing

KENILWORTH and WHITEHOUSE STATION, N.J., Aug. 28 /PRNewswire-FirstCall/ --Schering-Plough/Merck Pharmaceuticals (SPM) today announced that the New Drug Application filing for loratadine/montelukast has been accepted by the U.S. Food and Drug Administration (FDA) for standard review.

Schering-Plough/Merck Pharmaceuticals is seeking U.S. marketing approval of loratadine/montelukast for treatment of allergic rhinitis symptoms in patients who want relief from nasal congestion. If approved the medicine would be marketed as a prescription treatment by Schering-Plough/Merck Pharmaceuticals, a joint venture between Schering-Plough Corporation (NYSE:SGP) and Merck & Co., Inc. (NYSE:MRK) .

The medicine is a single tablet that contains the active ingredients of CLARITIN (R) (loratadine) and SINGULAIR (R) (montelukast sodium), both of which are indicated for the relief of symptoms of allergic rhinitis.

About Allergic Rhinitis
Allergic rhinitis affects more than 50 million people in the United States (1,2) and accounts for more than 14 million physician office visits each year.(3) It is one of the most costly chronic illnesses in the United States (4) and is estimated to cause 100 million days of lost work per year.(5)

There are two forms of allergic rhinitis: seasonal and perennial. Seasonal allergic rhinitis occurs only during certain times of the year and is commonly caused by allergies to tree, grass and weed pollen (often referred to as "hay- fever"). Perennial allergic rhinitis tends to last throughout the year and is caused by continuous exposure to allergens such as animal dander, indoor mold spores or house dust mites.(6)

Allergic rhinitis is activated when the immune system comes in contact with an allergen, such as dust, dander or pollen, and mistakenly identifies it as an intruder.(7) An allergic reaction results, involving the body's release of various inflammatory mediators, including histamine and leukotrienes, as a defense against the allergens, causing symptoms such as sneezing, nasal congestion, runny nose, and itching of the palate, eyes and nose.(8)

About loratadine/montelukast
In clinical trials, side effects were similar to placebo and included headache, fatigue and dry mouth. In clinical trials supporting the NDA, the combination product provided a consistent and clinically relevant effect on congestion that was not demonstrated with the individual components.

About CLARITIN
Schering-Plough received U.S. Food and Drug Administration (FDA) approval on November 27, 2002, for the over-the-counter (OTC) sale of the original prescription strength of CLARITIN Tablets.

About SINGULAIR
SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis (SAR) in adults and children two years and older, and for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and children six months and older. In clinical studies for both SAR and PAR, SINGULAIR was generally well tolerated. Adverse events varied by age. The most commonly reported adverse events, occurring at a frequency of >1% and at an incidence greater than placebo, regardless of causality assessment, were sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, headache, otitis media, pharyngitis and increased ALT. SINGULAIR is contraindicated in patients with hypersensitivity to any of its components.

References:
1 American Academy of Allergy Asthma & Immunology Topic of the Month: March 2007: Spring & Allergic Rhinitis. Available at https://www.aaaai.org/patients/topicofthemonth/0307/ Accessed August 1, 2007.

2 American Academy of Allergy Asthma & Immunology Tips to Remember: Rhinitis. Available at https://www.aaaai.org/conditions-and-treatments/library/at-a-glance/rhinitis.aspx. Accessed August 1, 2007.

3 CDC. National Hospital Ambulatory Medical Care Survey: 2004 Emergency Department Summary. No 372. June 23, 2006. Available at https://www.cdc.gov/nchs/data/ad/ad372.pdf

4 Goetzel R, et al. Health, absence, disability, and presenteeism cost estimates of certain physical and mental health conditions affecting U.S. employers. Journal of Occupational and Environmental Medicine. 2004;46:398- 412.

5 Bellanti JA, Wallerstedt DB. Allergic rhinitis update: epidemiology and natural history. Allergy Asthma Proc 2000;21:367-370.

6 Journal of Allergy and Clinical Immunology: July 2001; Volume 108, Issue 1, Part 2: S2-S8

7 American Academy of Allergy Asthma & Immunology Tips to Remember: Rhinitis. Available at https://www.aaaai.org/conditions-and-treatments/library/at-a-glance/rhinitis.aspx. Accessed July 25, 2007

8 Adapted from American Academy of Allergy Asthma & Immunology Tips to Remember: Rhinitis. Available at https://www.aaaai.org/conditions-and-treatments/library/at-a-glance/rhinitis.aspx. Accessed July 25, 2007

Source: Schering-Plough/Merck Pharmaceuticals

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