Schering-Plough (SGP) and Merck (MRK) Announce Withdrawal of NDA for Loratadine/Montelukast Combination Tablet

June 27, 2008 8:27 AM EDT

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.[SM]

Related Categories

FDA

Stocks Mentioned

Add Your Comment

Name

Subject

Body

Verification can't see the text?
click here to refresh the image.
what's this?