FDA issues not-approvable letter to Schering-Plough, Merck

KENILWORTH and WHITEHOUSE STATION, N.J. Schering-Plough and Merck have received a not-approvable letter from the Food and Drug Administration for a drug that combines the allergy medications loratadine, the generic of Claritin and montelukast, the generic of Singulair.

The application filing for loratadine/montelukast was accepted by the FDA for standard review on August 26, 2007.

Both drugs are indicated for the treatment of allergic rhinitis symptoms in patients who want relief from nasal congestion.