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Merck/Schering withdraw Loratadine/Montelukast NDA and Terminate Collaboration

Posted on June 27, 2008 by crimsoncanary

Schering-Plough and Merck have withdrawn the NDA for the loratadine/montelukast and announced that they will terminate the joint venture which was formed to develop and market a fixed-combination product that would combine loratadine and montelukast. This follows the receipt of a not-approvable letter from the FDA in April 2008.

Filed under: Uncategorized | Tagged: D4, FDA, H1, Histamine, Histamine H1, Leucotriene, Leucotriene D4, Licensing, Loratadine, Merck, Montelukast, regulatory, Schering-Plough

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