FDA sets advisory committee meeting for potential switch of Merck's Singulair Allergy tablets

SILVER SPRING, Md. — The Food and Drug Administration on Friday announced a meeting of the Nonprescription Drugs Advisory Committee on May 2 to discuss the potential switch of Merck's Singulair Allergy tablets. 

The proposed OTC use is "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposes to label the product for OTC use in adults 18 years and older. 

Prescription-only Singulair is currently used to treat outdoor allergies that happen part of the year (seasonal allergic rhinitis) in adults and children ages 2 years and older, and indoor allergies that happen all year (perennial allergic rhinitis) in adults and children ages 6 months and older.

As a prescription remedy, Singulair is also indicated to prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 12 months and older, as well as to prevent exercise-induced asthma in people 6 years of age and older. However, there is nothing suggesting that OTC Singulair Allergy will be indicated to treat or prevent any asthma symptoms. 

 

 

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