Lupin Secures USFDA Approval for Innovative Injectable Schizophrenia Treatment
Lupin Ltd has gained USFDA approval for its generic risperidone injectable suspension, used for schizophrenia and bipolar disorder in adults. This marks Lupin's first product utilizing Nanomi BV's technology, with 180-day exclusivity, aiming to expand global access to complex injectables through continued innovation.
- Country:
- India
Lupin Ltd, a prominent pharmaceutical company, announced that it has received approval from the United States Food and Drug Administration (USFDA) for its generic version of risperidone extended-release injectable suspension. This medication is utilized in the treatment and maintenance of schizophrenia and bipolar disorder among adults.
The approval pertains to the abbreviated new drug application for risperidone in extended-release injectable form, available in 25 mg, 37.5 mg, and 50 mg single-dose vials. This development represents Lupin's inaugural product using the cutting-edge technology of its subsidiary, Nanomi BV, earning a 180-day competitive generic therapies exclusivity.
Vinita Gupta, CEO of Lupin, hailed the first-cycle approval as a testament to the company's expertise in complex injectables. Lupin aims to leverage Nanomi's innovative platform for creating novel long-acting injectables that address unmet patient needs, enhancing drug delivery efficacy and safety.
(With inputs from agencies.)
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- Lupin
- USFDA
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- risperidone
- schizophrenia
- bipolar
- injectable
- suspension
- pharmaceutical
- Nanomi
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