No to Merck & Co/S-P combo allergy drug
US drug majors Schering-Plough and Merck & Co have received a "not-approvable" letter from the US Food and Drug Administration for their proposed combination of Claritin (loratadine) and Singulair (montelukast).
The companies filed a New Drug Application for a single tablet combining Merck's Singulair with Schering-Plough's Claritin, both treatments for allergic rhinitis, in August 2007 (Marketletter September 3, 2007).
The decision does not affect the availability or continued use of Singulair, or non-prescrition drug Claritin. The companies said in a press statement that they were evaluating the agency's response.
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