Aurobindo acquires FDA nod for generic Northera

Levy

The Food and Drug Administration has given its stamp of approval for Aurobindo’s droxidopa capsules, in dosage strengths of 100 mg, 200 mg, and 300 mg. 

The product is the generic of Lundbeck’s Northera capsules.

Doxidopa capsules are 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 caused by primary autonomic failure Parkinson’s disease, multiple system atrophy, and pure autonomic failure, dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy.

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