The Food and Drug Administration (FDA) has roflumilast (DalirespTM, Forest) approved for the treatment of patients with severe chronic obstructive pulmonary disease (COPD).
The phosphodiesterase4 inhibitors (PDE-4) inhibitor roflumilast is indicated for the reduction in the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and exacerbations of VTE. Roflumilast is not a bronchodilator and is not suitable for the treatment of acute bronchospasm.
by the European Commission roflumilast (Daxas) already admitted in June 2010.
Source:
press release the FDA from 1 March 2011
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