Search Orphan Drug Designations and Approvals
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Generic Name: | droxidopa | ||||||||||||||||
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Trade Name: | NORTHERA | ||||||||||||||||
Date Designated: | 01/17/2007 | ||||||||||||||||
Orphan Designation: | Treatment of neurogenic symptomatic orthostatic hypotension in patients with primary autonomic failure, dopamine-beta-hydroxylase deficiency, and nondiabetic autonomic neuropathy. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Lundbeck LLC 3530 Toringdon Way, Suite 200 Charlotte, North Carolina 28277 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | droxidopa |
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Trade Name: | NORTHERA | |
Marketing Approval Date: | 02/18/2014 | |
Approved Labeled Indication: | Treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. | |
Exclusivity End Date: | 02/18/2021 | |
Exclusivity Protected Indication* : | Treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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