#USA #FDA Approval #Naples #Lupin #risperidone

Lupin Receives FDA Approval for Long-Acting Injectable Risperidone

Lupin Limited has successfully secured approval from the U.S. Food and Drug Administration (FDA) for its long-acting injectable formulation of risperidone, a critical step for the company as it introduces its first product based on Nanomi's advanced technology.

This newly approved drug, designed as a once-monthly injection available in multiple dosing options (25 mg, 37.5 mg, and 50 mg vials), represents a significant advancement in patient care and compliance for those suffering from schizophrenia and bipolar disorder. With a 180-day exclusivity under the Current Good Manufacturing Practice (CGT), this product is poised to capture a share of the market for extended-release medications.

Vinita Gupta, CEO of Lupin, expressed her enthusiasm regarding this new FDA approval, emphasizing the resourcefulness and expertise of the research and development teams. This achievement is not merely a validation of the Nanomi platform but a reflection of Lupin's broader commitment to enhancing patient access to complex injectable products worldwide.

Lupin's commitment to the development of long-acting injectables (LAIs) stems from a desire to address unmet needs in the healthcare sector, particularly in psychiatric treatment. The innovative technology utilized in this product allows for precise particle control, facilitating the creation of microspheres that ensure a prolonged release of medication. This technology not only enhances injection comfort through the use of smaller needles but also stabilizes drug concentrations, improving overall patient experience.

Lupin’s Chief Scientific Officer, Dr. Shahin Fesharaki, noted the significance of the risperidone approval as a critical validation of their technological platform. He mentioned that it marks a pivotal juncture in the company’s journey toward producing novel long-acting injectable therapies across a variety of clinical areas.

Overview of the Product

The long-acting injectable risperidone is a generic equivalent to the well-known risperidone formulation, Risperdal Consta®. This therapy is aimed at managing symptoms of schizophrenia and providing support for bipolar disorder, either alone or in conjunction with other medications such as lithium or valproate. The Risperdal Consta® product previously generated approximately $190 million in annual sales in the U.S., showcasing the significant market potential for Lupin’s new offering.

About Lupin

Lupin Limited, headquartered in Mumbai, India, is recognized as a leading global pharmaceutical entity, distributing products across over 100 markets. The company’s portfolio encompasses a diverse range of pharmaceutical offerings, including both branded and generic formulations, biotech products, and active pharmaceutical ingredients. With a commitment to enhancing patient outcomes, Lupin boasts a robust presence in therapeutic areas such as respiratory, cardiovascular, diabetes care, infectious diseases, gastrointestinal health, and more. Its state-of-the-art manufacturing facilities and dedicated workforce of over 24,000 professionals support its strategic vision to be a global leader in healthcare.

For more detailed information about Lupin and its latest innovations, please visit Lupin's official website or follow them on LinkedIn.

For further insights into Nanomi, check out their website at Nanomi's site or connect with them on LinkedIn.

Conclusion

The FDA approval of this long-acting injectable risperidone symbolizes a crucial step not just for Lupin but for the evolution of injectable pharmaceuticals, enhancing adherence and providing new options for patients grappling with mental health challenges. As Lupin continues to innovate, the future looks promising for the realization of advanced therapeutic solutions in the pharmaceutical industry.