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
|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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