Sunovion Pharmaceuticals said today that the FDA accepted the revised new drug application for its eFlow chronic obstructive pulmonary disease drug-device combo.
The submission follows a complete response letter that the FDA issued Sunovion in May. The Marlborough, Mass.-based company didn’t provide details as to why the FDA denied its initial application.
The U.S. regulatory watchdog is slated to make a decision for the resubmitted application by December 15.
Sunovion’s investigational eFlow closed-system nebulizer delivers a long-acting muscarinic antagonist bronchodilator, glycopyrrolate, to reduce airflow obstruction in COPD patients.
“We look forward to working with the FDA during their review of the SUN-101/eFlow resubmission, which, if approved, would be the 1st nebulized LAMA for patients with COPD in the United States,” Dr. Antony Loebel, exec VP & chief medical officer, said in prepared remarks. “Building on the strength of our heritage in nebulized treatment for COPD, the development of this innovative drug-device combination underscores our commitment to ensuring patients have choices in medication and delivery options with the goals of individualizing and optimizing treatment.”
Heidi Dohse was diagnosed with a rare arrhythmia in 1982 and has been 100% pacemaker dependent for over 30 years. With the help of wearable devices, she has been able to pursue her dream to become a competitive cyclist.
You can hear her story and more when you register for DeviceTalks Boston, October 8-10.
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