Merck has withdrawn request for regulatory approval for the drug Dulera, which is currently being marketed in the US, according to an article The Wall Street Journal Online. The medication was to be marketed as Zenhale.
Dulera is a combination asthma medication that includes the steroid in Asmanex and the LABA medication Foradil.
In a filing to the Securities and Exchange Commission, Merck acknowledged that it had informed the European Medicines Agency (EMA) it was going to :
withdraw the application for Zenhale to address questions outstanding between the Company and the Committee for Medicinal Products for Human Use of the EMA. The Company expects to resubmit the application in the future.
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