Aurobindo Pharma receives USFDA approval for Droxidopa Capsules

Aurobindo Pharma receives USFDA approval for Droxidopa Capsules

Aurobindo Pharma Limited is pleased to announce that the company has Obtained final Acceptance from The US Food & Drug Administration (USFDA) to manufacture and promote Droxidopa Capsules, 100 mg, 200 mg and 300 mg. Droxidopa Capsules are generic version of Lundbeck NA Ltd's Northera® Capsules. The product is expected to be launched soon.

The approved product has an estimated market size of US$ 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 brought on by primary autonomic failure, dopamine beta-hydroxylase lack and non-diabetic adrenal disorder.

This is the 24th ANDA to be accepted from Unit-X formulation facility in Hyderabad, India employed for Manufacturing oral products. Aurobindo now has a total of 469 ANDA approvals (440 Final approvals) and 29 tentative approvals) from USFDA.