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Northera Approval History

FDA Approved: Yes (First approved February 18, 2014)
Brand name: Northera
Generic name: droxidopa
Dosage form: Capsules
Company: Chelsea Therapeutics
Treatment for: Hypotension

Northera (droxidopa) is an orally active synthetic precursor of norepinephrine indicated for the treatment of neurogenic orthostatic hypotension.

Development History and FDA Approval Process for Northera

DateArticle
Feb 18, 2014Approval FDA Approves Northera to treat Neurogenic Orthostatic Hypotension
Feb 14, 2014Chelsea Therapeutics Issues Statement Regarding Postponement of Northera NDA PDUFA Date
Jan 14, 2014FDA Advisory Panel Recommends Approval of Chelsea Therapeutics' Northera (Droxidopa) for the Treatment of Symptomatic nOH
Oct  9, 2013Chelsea Therapeutics Announces FDA Advisory Committee to Review Northera
Sep  4, 2013Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission
Aug 15, 2013Chelsea Therapeutics Announces Submission of Additional Information for Northera NDA
Jul 17, 2013Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission
Jul  9, 2013Chelsea Therapeutics Resubmits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH
Feb 20, 2013Chelsea Therapeutics Receives FDA Guidance for a Northera (Droxidopa) NDA Resubmission With Study 306B
Jul  3, 2012Chelsea Therapeutics Provides an Update on Northera (droxidopa) Regulatory Status and Development Program
May 22, 2012Chelsea Therapeutics Completes End-of-Review Meeting With FDA for Northera (droxidopa) NDA
Mar 28, 2012Chelsea Therapeutics Receives Complete Response Letter from Food and Drug Administration for Northera (droxidopa) Capsules
Feb 24, 2012FDA Advisory Panel Recommends Approval of Chelsea's Northera (droxidopa) for the Treatment of Symptomatic Neurogenic OH
Feb 14, 2012Chelsea Therapeutics CEO to Review Northera NDA and Provide an Update on Upcoming Advisory Committee Meeting During Presentation at BIO CEO
Jan  5, 2012Chelsea Therapeutics Announces FDA Advisory Committee Meeting Date for Review of Northera NDA for the Treatment of Symptomatic NOH
Sep 28, 2011Chelsea Therapeutics Submits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH
Dec 20, 2010Chelsea Therapeutics Accelerates Northera NDA Filing Following Meeting With FDA
Feb  9, 2010Chelsea Therapeutics Announces Advancements in Neurogenic Orthostatic Hypotension Registration Program

Further information

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