By Chris Wack

 

Supernus Pharmaceuticals Inc. said it has resubmitted its New Drug Application for its apomorphine infusion device SPN-830 for the continuous treatment of motor fluctuations in Parkinson's Disease.

The biopharmaceutical company said that following the original submission of the NDA for SPN-830, the U.S. Food and Drug Administration issued a Refusal to File letter in November 2020, indicating the NDA wasn't sufficiently complete to permit a substantive review.

The FDA provided additional clarity related to the contents of the November 2020 RTF letter and the requirements for resubmission during a Type A meeting with Supernus in March 2021.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

December 08, 2021 08:52 ET (13:52 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.
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