FDA panel advises against Rx-to-OTC switch of Singulair

WASHINGTON — The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted 11-4 opposed to switching Merck's allergy remedy Singulair from Rx-to-OTC, according to an Associated Press report. 

According to the report, NDAC panelists questioned the safety of Singulair as an OTC remedy, especially considering patients could use it as an off-label remedy for the more serious condition asthma.  

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. 

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.

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