droxidopa

FDA Drug Profile — Northera, droxidopa, Droxidopa

Drug Details

Generic Name
droxidopa
Brand Names
Northera, droxidopa, Droxidopa
Application Number
NDA203202
Sponsor
Lundbeck Pharmaceuticals LLC
NDC Codes
15
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
DROXIDOPA

Indications and Usage

1 INDICATIONS & USAGE Droxidopa capsules is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of droxidopa capsules should be assessed periodically. Droxidopa capsule is indicated for the treatment of orthostatic dizziness, light headedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of Droxidopa capsules should be assessed periodically ( 1 ).