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Pharmaceuticals / Submissions and Approvals

Sunovion Receives Complete Response Letter for SUN-101/eFlow NDA

June 14, 2017
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The FDA issued a complete response letter to Sunovion for its SUN-101/eFlow NDA for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease.

SUN-101 is a long-acting bronchodilator delivered via the company’s proprietary eFlow closed system nebulizer, currently in development as a treatment for patients with moderate-to-very-severe COPD.

The CRL does not require Sunovion to conduct any additional clinical studies. The company said it plans to work with the FDA to find the best way to move forward.

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