Lupin launches generic equivalent of Northera capsules in US
Mumbai: Global pharma major Lupin Limited has recently announced the launch of Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, having received an approval from the United States Food and Drug Administration (USFDA).
The product is manufactured at Lupin's facility in Nagpur, India.
Droxidopa Capsules, 100 mg, 200 mg, and 300 mg is a generic equivalent of Northera Capsules, 100 mg, 200 mg, and 300 mg, of Lundbeck NA Ltd., 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 294 million in the U.S. (IQVIA MAT July 2021).
Prior to this, Lupin had launched the authorized generic version of Duexis (ibuprofen and famotidine) Tablets, 800 mg/26.6 mg, of Horizon Medicines LLC indicated in US indicated for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer in patients who are taking ibuprofen for those indications.
Read also: Lupin unveils generic Duexis tablets in US
Headquartered in Mumbai, India, Lupin 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.
Read also: Submit detailed rationale for developing Pantoprazole modified dosage form: CDSCO panel tells Lupin
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