Lupin gets USFDA nod for generic drug

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Drugmaker Lupin on Friday stated it has obtained approval from the US well being regulator to market Droxidopa capsules, used to deal with dizziness. The firm has obtained approval from the US Food and Drug Administration (USFDA) for Droxidopa capsules in strengths of 100 mg, 200 mg, and 300 mg, Lupin stated in a press release.

The firm’s product is a generic model of Lundbeck NA’s Northera capsules, it added. The product might be manufactured on the firm’s Nagpur-based facility, the Mumbai-based drugmaker famous.

Droxidopa Capsules are indicated for the therapy of orthostatic dizziness, lightheadedness in sufferers with symptomatic neurogenic orthostatic hypotension (nOH) brought on by major autonomic failure (Parkinson’s illness, a number of system atrophy, and pure autonomic failure), dopamine beta- hydroxylase deficiency, and non-diabetic autonomic neuropathy.

As per IQVIA MAT December 2020 gross sales information, Droxidopa capsules had estimated annual gross sales of USD 352 million within the US.





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