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FDA grants expanded use of Merck & Co’s Singulair

Merck & Co's asthma medication, Singulair, has gained FDA approval to be marketed as a treatment for perennial allergic rhinitis in adults and children.

Singulair (montelukast sodium) is now approved to be used to treat asthma, seasonal allergies and perennial allergic rhinitis (PAR). The medication can be taken by adults and children six months of age and older to treat the symptoms of PAR.

Merck describes the medication as a convenient once-a-day tablet, which has been proven to help relieve a broad range of indoor and outdoor allergy symptoms for up to 24 hours. According to the company, allergic rhinitis is one of the most common allergic conditions around, symptoms of which afflict approximately 50 million US citizens. Of this figure, Merck estimates 55 to 80% of these patients suffer from PAR.

Singulair, which was approved for the treatment of the symptoms of seasonal allergic rhinitus (SAR) in 2003, is different from most oral allergy medications, which block histamine, in that it blocks leukotrienes, an important contributor to allergy symptoms.

The use of Singulair is expected to continue expanding; Merck has already filed for US approval for the drug as a treatment for exercise-induced bronchoplasm. Furthermore, the company is expected to file for approval for intravenous use of the drug as a treatment for acute asthma early next year.