Schering-Plough Europe has withdrawn the marketing authorisation application for asthma treatment Zenhale.
The company said it has withdrawn the application as it was not able to meet the CHMP’s request for further information within the agreed timescale.
Zenhale was intended to be used for long-term, twice-daily maintenance treatment of asthma, including reduction of asthma exacerbations, in adults and children aged 12 years or older.
The application was submitted to the European Medicines Agency under a centralised procedure on 3 August 2009.
At the time of the withdrawal, the application was under review by the CHMP. The company will now be allowed to make a new application at a later date.