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22 April, 2021 20:47 IST
Aurobindo Pharma gets USFDA nod for Droxidopa Capsules
Source: IRIS | 19 Feb, 2021, 07.34PM
Rating: NAN / 5 stars.
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 Aurobindo Pharma, a mid-size pharmaceutical company, on Friday announced that the company 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 NA's Northera Capsules. The product will be launched immediately.

The approved product has an estimated market size of USD 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.

 Shares of the company declined Rs 23.15, or 2.54%, to settle  at  Rs 888.65.  The total volume of shares traded  was  155,734 at  the BSE (Friday).



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