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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.