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Schering-Plough Corp. and Merck & Co., Inc. announce the withdrawal of the New Drug Application (NDA) for the loratadine/montelukast combination tablet
KENILWORTH and WHITEHOUSE STATION, NJ, USA | June 27, 2008 | Schering-Plough Corp. (NYSE: SGP) and Merck & Co., Inc. (NYSE: MRK) announce the withdrawal of the New Drug Application (NDA) for the loratadine/montelukast combination tablet.
The companies also terminated the Schering-Plough/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/Schering-Plough cholesterol joint venture.
The U.S. Food and Drug Administration (FDA) issued on April 25, 2008 a not-approvable letter for the proposed fixed-dose combination of loratadine and montelukast.
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.
SOURCE Schering-Plough Corp.; Merck & Co., Inc. |
