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Lupin Receives Approval for Droxidopa Capsules
Mumbai, Baltimore, February 19, 2021: Global pharma major Lupin Limited (Lupin) today announced that it has received approval for its Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, from the United States Food and Drug Administration, to market 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.
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 beta-hydroxylase 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).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. 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 Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions. For the nine months ended December 31, 2020, the Company invested 9.8% of its revenues on research and development.
Lupin has fifteen manufacturing sites, seven research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
Please visit www.lupin.com for more information.
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*Safe Harbor Statement
Northera® is a registered trademark of Lundbeck NA Ltd.