Aurobindo Pharma gets USFDA nod for generic Droxidopa capsules

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Drug main on Friday stated it has acquired remaining approval from the US well being regulator to fabricate and market Droxidopa capsules, used to deal with dizziness and lightheadedness. The authorized product is a generic model of Lundbeck NA Ltd’s Northera capsules.

The firm has acquired remaining approval from the US Food and Drug Administration (USFDA) to fabricate and market Droxidopa capsules within the strengths of 100 mg, 200 mg and 300 mg, Aurobindo Pharma stated in a regulatory submitting.

The firm stated the product might be launched instantly.

Droxidopa is indicated for the remedy of orthostatic dizziness and lightheadedness in grownup sufferers with symptomatic neurogenic orthostatic hypotension (low blood stress).

Quoting IQVIA information, Aurobindo Pharma stated the authorized product has an estimated market dimension of USD 352 million for the twelve months ending December 2020.

Aurobindo now has a complete of 469 abbreviated new drug utility (ANDA) approvals (440 remaining and 29 tentative) from USFDA.

Shares of Aurobindo Pharma have been buying and selling 1.21 per cent decrease at Rs 901.60 apiece on BSE.





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