According to the European Medicines Agency, Schering-Plough Europe (Merck) has withdrawn its marketing authorization application for its Zenhale mometesone furoate/formoterol fumarate MDI. The company said that it was unable to provide data requested by the Committee for Medicinal Products for Human Use (CHMP) by the deadline. Zenhale is marketed as Dulera in the US, where it was approved by the FDA in June 2010. Read the EMA press release.
Zenhale application withdrawn
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