Lupin obtains FDA OK for generic Northera

The Food and Drug Administration has given Lupin the green light for droxidopa capsules, in dosage strengths of 100 mg, 200 mg, and 300 mg.

The product, which is the generic of Lundbeck’s Northera capsules, is indicated for 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.

Lupin's generic Northera capsules will be manufactured at its facility in Nagpur, India.

Droxidopa capsules had a market value of $352 million, according to IQVIA December 2020 data.