Sunovion's NDA for SUN-101/eFlow accepted by FDA

14 October 2016

The US Food and Drug Administration has accepted for review the New Drug Application (NDA) from Sunovion Pharmaceuticals for SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist (LAMA), delivered via PARI’s innovative investigational eFlowclosed system nebulizer, for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is May 29, 2017, said Sunovion, a US subsidiary of Japanese pharma company Sumitomo Dainippon (TYO: 4506).

Would become first nebulized LAMA for patients with COPD if approved

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