FDA accepts Sunovion's SUN-101 resubmission for COPD

In June, the Sunovion Pharmaceuticals Inc. unit of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said FDA accepted for review a resubmitted NDA for SUN-101 as a long-term maintenance treatment for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). Its PDUFA date is Dec. 15.

FDA issued a complete response letter for the product in May. The company said the agency did not require additional clinical trials. Sunovion did not disclose a specific reason for the CRL when it was issued (see BioCentury, June 5)...