October 13, 2016
Sunovion files new drug application
Sunovion is headquartered in Marlborough.
By Sam Bonacci
Marlborough’s Sunovion has filed a new drug application with the U.S. Food and Drug Administration for ongoing treatment of chronic obstructive pulmonary disease that can make it difficult to breathe.
Sunovion announced Thursday that the FDA has accepted for review a new drug application for SUN-101. The long-acting drug is delivered through a closed-system nebulizer, and the delivery system and drug are both unique to this application. Together, they reduce the time needed for a treatment of this condition that is estimated to impact up to 15.7 million adults in the U.S.
The submission comes following human trials, according to Sunovion, and a decision on the drug is expected by the end of May 2017.
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