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
|Oct 9, 2013||Chelsea Therapeutics Announces FDA Advisory Committee to Review Northera|
|Sep 4, 2013||Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission|
|Aug 15, 2013||Chelsea Therapeutics Announces Submission of Additional Information for Northera NDA|
|Jul 17, 2013||Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission|
|Jul 9, 2013||Chelsea Therapeutics Resubmits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH|
|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|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.