U.S. FDA nod for Aurobindo’s Droxidopa capsules


Drugmaker Aurobindo Pharma has received final approval from the U.S. Food and Drug Administration (US FDA) to manufacture and market Droxidopa capsules, 100 mg, 200 mg and 300 mg.

Droxidopa Capsules are generic version of Lundbeck NA’s Northera capsules and will be launched immediately, the company said on Friday. The approved product has an estimated market size of $352 million for the 12 months ending December 2020, a release said quoting IQVIA numbers.

Droxidopa is indicated for the treatment of orthostatic dizziness and lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure, dopamine beta-hydroxylase deficiency and non-diabetic autonomic neuropathy.

The release said this is the 24th ANDA to be approved out of Unit-X formulation facility in Hyderabad, used for manufacturing oral products. Aurobindo has a total of 469 ANDA approvals (440 final approvals and 29 tentative approvals) from U.S. FDA.

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