Lupin gets USFDA nod for generic equivalent of Northera Capsules
Mumbai, Baltimore: Global pharma major, Lupin Limited, has recently announced that the company has received approval for its Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, from the United States Food and Drug Administration (USFDA).
The product is a generic equivalent of Northera Capsules, 100 mg, 200 mg, and 300 mg, of Lundbeck NA Ltd.
The product will be manufactured at Lupin's facility in Nagpur, India.
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Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, are indicated for the treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine betahydroxylase deficiency, and non-diabetic autonomic neuropathy.
Droxidopa Capsules (RLD: Northera) had estimated annual sales of USD 352 million in the U.S. (IQVIA MAT December 2020)
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The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle-East regions.
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