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loratadine and montelukast

loratadine and montelukast

Treatment for Allergic Rhinitis

Loratadine/Montelukast NDA Withdrawn

Schering-Plough and Merck Announce Withdrawal of Loratadine/Montelukast NDA and Termination of Respiratory Joint Venture

KENILWORTH and WHITEHOUSE STATION, N.J., June 27, 2008 /PRNewswire-FirstCall/ -- Schering-Plough Corp. and Merck & Co., Inc. 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.

Posted: June 2008

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