ARTICLE | Clinical News

Aclidinium bromide regulatory update

April 2, 2012 7:00 AM UTC

FDA extended the PDUFA date by 3 months for an NDA from Forest for aclidinium bromide to treat bronchospasm associated with chronic obstructive pulmonary disease (COPD). The new date is in July; it was in April. Specific dates are not disclosed. Forest and partner Almirall S.A. said the agency did not request additional data. In February, an FDA committee voted 12-2 that the benefit-risk profile for aclidinium bromide supports approval in the indication (see BioCentury, Feb. 27). ...