The drug is used to treat dizziness and lightheadedness
Drug major Aurobindo Pharma has received final approval from the US health regulator to manufacture and market Droxidopa capsules, used to treat dizziness and lightheadedness. The approved product is a generic version of Lundbeck NA’s Northera capsules.
The company has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market Droxidopa capsules in the strengths of 100 mg, 200 mg and 300 mg, Aurobindo Pharma said in a regulatory filing.
The company said the product will be launched immediately.
Droxidopa is indicated for the treatment of orthostatic dizziness and lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension (low blood pressure).
Quoting IQVIA data, Aurobindo Pharma said the approved product has an estimated market size of $ 352 million for the twelve months ending December 2020.
Aurobindo now has a total of 469 abbreviated new drug application (ANDA) approvals (440 final and 29 tentative) from US FDA.