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Aurobindo Pharma gets USFDA nod for generic hypotension drug

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The drug maker said that it received final approval from the US Food & 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. "The product will be launched immediately, the company said in a BSE filing made during market hours today.

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 light headedness 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 abbreviated new drug application (ANDA) to be approved out of Unit-X formulation facility in Hyderabad, India used for manufacturing oral products.

The company now has a total of 469 ANDA approvals (440 Final approvals and 29 tentative approvals) from USFDA.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients.

The drug maker's consolidated net profit jumped 317.70% to Rs 2,946.32 crore on a 9.5% rise in net sales at Rs 6,353.13 crore in Q3 December 2020 over Q3 December 2019.

The scrip shed 0.64% to Rs 905.95 on the BSE. It traded in the range of 901 and 921.20 so far during the day.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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First Published: Fri, February 19 2021. 11:33 IST