US : FDA panel pans over-the-counter Singulair proposal

The Nonprescription Drugs Advisory Committee of the US Food and Drug Administration (FDA) has voted against recommending that montelukast (Singulair Allergy, Merck) be approved as an over-the-counter (OTC) drug for the treatment of allergic rhinitis (AR).

The Food and Drug Administration’s panel of experts voted 11-4 Friday against making the drug available without a prescription. Merck sells Singulair via prescription for asthma and allergies.

Singulair was once Merck’s best-selling drug, but sales have plummeted since the drug’s patent expired in mid-2012, exposing the brand to low cost generics.

Merck & Co. Inc. hopes to revive sales of the former blockbuster as an over-the-counter allergy medication.

But FDA’s advisers said the safety of Singulair as an over-the-counter treatment has not been established, particularly since patients could use it off-label for more serious conditions like asthma.

Agencies/Canadajournal