No FDA approval for over-the-counter use of montelukast

摘要

Merck have failed to get approval by the Non-Prescription Drugs Advisory Committee of the US Food and Drug Administration (FDA) for the use of montelukast (Singulair) as an over-the-counter treatment for allergic rhinitis. The drug is currently approved for prescription use in the treatment of allergic rhinitis, asthma, and exercise induced bronchoconstriction in children and adults. If it had been approved, montelukast would have become the first leukotriene agonist to reach the over-the-counter market, providing a different mechanism of action from other available drugs for allergic rhinitis.