Northera Approval Status 
- FDA approved: No
- Brand name: Northera
- Generic name: droxidopa
- Company: Chelsea Therapeutics International, Ltd.
- Treatment for: Hypotension
Northera (droxidopa) is an orally active synthetic precursor of norepinephrine in development for the treatment of neurogenic orthostatic hypotension.
FDA Approval Status for Northera
| Date | Article |
|---|
| Feb 20, 2013 | Chelsea Therapeutics Receives FDA Guidance for a Northera (Droxidopa) NDA Resubmission With Study 306B |
| Jul 3, 2012 | Chelsea Therapeutics Provides an Update on Northera (droxidopa) Regulatory Status and Development Program |
| May 22, 2012 | Chelsea Therapeutics Completes End-of-Review Meeting With FDA for Northera (droxidopa) Capsules New Drug Application |
| Mar 28, 2012 | Chelsea Therapeutics Receives Complete Response Letter from Food and Drug Administration for Northera (droxidopa) Capsules |
| Feb 24, 2012 | FDA Advisory Panel Recommends Approval of Chelsea's Northera (droxidopa) for the Treatment of Symptomatic Neurogenic OH |
| Feb 14, 2012 | Chelsea Therapeutics CEO to Review Northera NDA and Provide an Update on Upcoming Advisory Committee Meeting During Presentation at BIO CEO |
| Jan 5, 2012 | Chelsea Therapeutics Announces FDA Advisory Committee Meeting Date for Review of Northera NDA for the Treatment of Symptomatic NOH |
| Sep 28, 2011 | Chelsea Therapeutics Submits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH |
| Dec 20, 2010 | Chelsea Therapeutics Accelerates Northera NDA Filing Following Meeting With FDA |
| Feb 9, 2010 | Chelsea Therapeutics Announces Advancements in Neurogenic Orthostatic Hypotension Registration Program |
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