Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Droxidopa Capsules, 100 mg, 200 mg and 300 mg. Droxidopa Capsules are generic version of Lundbeck’s Northera Capsules. The product will be launched immediately.
The approved product has an estimated market size of $352 million for the twelve months ending December 2020, according to IQVIA. 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.
This is the 24th ANDA to be approved out of Unit-X formulation facility in Hyderabad, India used for manufacturing oral products. Aurobindo now has a total of 469 ANDA approvals (440 Final approvals and 29 tentative approvals) from USFDA.