Lupin Secures FDA Approval for Long-Acting Injectable Risperidone, Expanding Treatment Options for Schizophrenia and Bipolar I Disorder
New Delhi, India – September 11, 2025 – Lupin Limited, a leading global pharmaceutical company, is pleased to announce a significant milestone in its commitment to providing accessible and effective treatments. The company has received approval from the United States Food and Drug Administration (FDA) for its long-acting injectable risperidone, a crucial medication used in the management of schizophrenia and bipolar I disorder.
This approval marks a pivotal moment for Lupin, underscoring its dedication to advancing healthcare solutions and addressing unmet medical needs within the mental health sector. Long-acting injectable formulations offer a valuable therapeutic alternative for patients, particularly those who may struggle with adherence to daily oral medication regimens. This new product aims to improve treatment consistency and potentially enhance patient outcomes by providing a sustained release of risperidone over an extended period.
Risperidone is a well-established antipsychotic medication that has been widely used for decades to manage the symptoms of schizophrenia, a chronic and complex mental illness characterized by hallucinations, delusions, and disordered thinking. It is also an effective treatment for manic and mixed episodes associated with bipolar I disorder, a condition marked by extreme shifts in mood, energy, and activity levels.
The development and approval of this long-acting injectable formulation represent a significant investment in research and development by Lupin. The company has focused on creating a robust and reliable product that meets the stringent quality and safety standards set by the FDA. This achievement highlights Lupin’s technical expertise and its capability to bring complex generic and biosimilar products to market.
“We are incredibly proud to receive FDA approval for our long-acting injectable risperidone,” stated [Insert Name and Title of a Lupin Executive, e.g., Ms. Vinita Gupta, CEO, Lupin]. “This approval is a testament to our team’s hard work and dedication to enhancing patient care. We believe this long-acting formulation will be a valuable addition to the treatment landscape for individuals living with schizophrenia and bipolar I disorder, offering a more convenient and potentially more effective way to manage their conditions.”
The availability of this long-acting injectable risperidone is expected to provide healthcare professionals with a vital tool to support treatment adherence and improve the quality of life for patients and their families. Lupin is committed to ensuring broad access to this important medication and is working diligently to make it available to patients across the United States.
About Lupin Limited:
Lupin is a global pharmaceutical company driven by its purpose of being “For a healthier world.” The company is committed to providing affordable and innovative medicines in the fields of respiratory, gastrointestinal, cardiovascular, anti-infectives, and central nervous system (CNS) disorders, among others. Lupin is a significant player in the generics market and is also building a strong pipeline in biosimilars and specialty products. Lupin has a significant presence in North America, Europe, Japan, and India.
Forward-Looking Statements:
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and involve risks and uncertainties that could cause actual results to differ materially from those contained in the forward-looking statements. Lupin undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date of this press release.
Lupin obtiene la aprobación de la FDA de EE.UU. para risperidona inyectable de larga duración
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