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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: droxidopa
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
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.

Marketing approved:

1 Generic Name: droxidopa
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.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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