FDA Declines to Approve APL-130277 for Treating ‘Off’ Periods; More Information Requested
The U.S. Food and Drug Administration (FDA) has told Sunovion Pharmaceuticals that it is unable to approve APL-130277 (apomorphine sublingual film) in its present form for the treatment of Parkinson’s disease “off” periods. Sunovion submitted new drug application for APL-130277 in April 2018. Now the FDA has now…