Lupin gets US FDA approval for Droxidopa Capsules

Lupin announced that it has received approval for its Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, from the United States Food and Drug Administration, to market a generic equivalent of Northera Capsules, 100 mg, 200 mg, and 300 mg, of Lundbeck. The product will be manufactured at Lupin’s facility in Nagpur, India.

Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, 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, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy.

Droxidopa Capsules (RLD: Northera) had estimated annual sales of $352 million in the US (IQVIA MAT December 2020).