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ARTICLE | Clinical News

FDA accepts applications for Circassia COPD products Duaklir, Tudorza

August 17, 2018 3:32 AM UTC

Circassia Pharmaceuticals plc (LSE:CIR) said FDA accepted for review an NDA for Duaklir Pressair aclidinium bromide/formoterol fumarate to treat chronic obstructive pulmonary disease (COPD). The company also said the agency accepted an sNDA for Tudorza Pressair aclidinium bromide requesting inclusion of clinical data demonstrating cardiovascular safety and reduction of COPD exacerbations in the drug’s prescribing information. The PDUFA date for both applications is March 31, 2019.

Duaklir is a fixed-dose combination of Tudorza and long acting beta agonist (LABA) formoterol. Tudorza, which is approved for long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema, is an inhalable long-acting, selective M2 and M3 muscarinic receptor antagonist. Both products are delivered via the Pressair inhaler...