Supernus Pharmaceuticals Resubmits NDA for Parkinson's Disease Treatment
December 08 2021 - 9:07AM
Dow Jones News
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.
Supernus Pharmaceuticals (NASDAQ:SUPN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Supernus Pharmaceuticals (NASDAQ:SUPN)
Historical Stock Chart
From Sep 2023 to Sep 2024
