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This article was originally published in Scrip
The US FDA's advisory committee on pulmonary drugs voted 10-5 on 7 April that the agency should not approve the new drug application (NDA) from Forest Research Institute to market roflumilast (Daxas; licensed from Nycomed) for maintenance treatment of chronic obstructive pulmonary disease (COPD) associated with bronchitis in patients at risk of exacerbations.
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