ALTANA Has Withdrawn the EU Marketing Authorisation Application for Daxas


ALTANA announced that it has withdrawn the European Marketing Authorisation Application (MAA) for Daxas® (roflumilast).

ALTANA Pharma has taken this decision after consulting with the EMEA today. The submission of a new MAA will be pursued, after further clinical data are available.

ALTANA Pharma is committed to continue the development of Daxas® and will pursue further clinical studies to strengthen the anti-inflammatory product profile and possible market potential of Daxas®.

The phosphodiesterase4 (PDE4)-inhibitor Daxas® (roflumilast) is an oral investigational, steroid free anti-inflammatory agent being studied for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.

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