Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Monteluk...(ennial allergic rhinitis tends to lastth...),Health
ennial 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.
About Schering-Plough/Merck Pharmaceuticals
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