Schering-Plough and Merck & Co have announced the withdrawal of the new drug application for the loratadine and montelukast combination tablet.
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The companies also terminated the Schering-Plough and Merck Pharmaceuticals respiratory joint venture, which was formed in May 2000 to develop and market a fixed-combination product that would combine loratadine and montelukast. This action has no impact on the business of the Merck and Schering-Plough cholesterol joint venture.
As a result of the termination of the respiratory joint venture, Schering- Plough expects to receive payments totaling $105 million from Merck as specified in the joint venture agreements which Schering-Plough will recognize over the remaining three quarters of 2008.
The FDA issued on April 25, 2008 a not-approvable letter for the proposed fixed-dose combination of loratadine and montelukast.
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