Schering-Plough and MSD withdraw new drug application

Schering-Plough and Merck, Sharp & Dohme (MSD) have withdrawn their new drug application for the loratadine and montelukast combination tablet.

In addition, the companies have also ended their respiratory joint venture which was set up in 2000 in order to develop a fixed-combination product that would combine the two drugs.

However, the companies have insisted this move will have no impact on their cholesterol joint venture.

This comes after the US Food and Drug Administration failed to approve the proposed fixed-dose combination of loratadine and montelukast in April.

Now the respiratory joint venture has been terminated, Schering-Plough is set to receive $105 million (52.6 million pounds) from MSD as specified in their joint venture agreement.

Last week, MSD revealed results which showed that rotavirus disease was reduced in the US between November 2007 and May 2008.

The company has said further investigations will be carried out to ascertain if this reduction was due to the use of the vaccine Rotateq (rotavirus vaccine, live, oral, pentavalent).