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Altana pulls application to market Daxas
New York, Nov. 15 - Altana AG said it has withdrawn its European Marketing Authorization Application for Daxas (roflumilast).
The company said it took the decision after consulting with the European Medicines Agency (EMEA) but added that it may make a new submission after more clinical data is available.
Altana said it is "committed to continue the development of Daxas" and said it will carry out more studies.
Daxas is a phosphodiesterase4 (PDE4)-inhibitor, administered orally and intended to be a steroid-free anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease and asthma.
Altana is a Bad Homburg, Germany, pharmaceutical company.
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