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Aurobindo receives FDA approval for droxidopa capsules

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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Droxidopa Capsules, 100mg, 200mg, and 300mg. Aurobindo Pharma’s Droxidopa Capsules, 100mg, 200mg, and 300mg are an AB-rated generic equivalent to the reference listed drug (RLD), Northera Capsules 100mg, 200mg, and 300mg marketed by Lundbeck NA Ltd.

Droxidopa 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 (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.


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