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news.Schering-Plough/Merck Pharmaceuticals has received a not-approvable letter from the FDA for a proposed fixed combination of loratadine and montelukast for the treatment of allergic rhinitis symptoms in patients who want relief from nasal congestion.
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The new drug application filing for loratadine/montelukast was accepted by the FDA for standard review on August 26, 2007. The medicine is a single tablet that contains the active ingredients of Claritin (loratadine) and Singulair (montelukast sodium), both of which are indicated for the relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.
Schering-Plough/Merck Pharmaceuticals is evaluating the agency’s response. The FDA decision does not impact the availability or continued use of Claritin or Singulair.