Amneal’s Injectable Extended-Release Suspension of Risperidone Receives FDA Approval to Treat Schizophrenia

The FDA approved an injectable extended-release suspension of risperidone (Amneal Pharmaceuticals)—which references Risperdal Consta (Janssen Biotech)—for the treatment of patients with schizophrenia. With this approval, the extended-release formulation is available in 12.5-, 25-, 37.5-, and 50-mg vials.¹

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Schizophrenia is a mental health condition that can affect how patients think, feel, and behave. It may result in a mix of hallucinations (hearing and seeing things that are not observed by others), delusions (firm beliefs about things that are untrue), and disorganized thinking and behavior, according to Mayo Clinic. Symptoms may vary in type and severity, meaning that treatments to manage them are crucial. Often, schizophrenia is diagnosed in the late teen years to early thirties, with symptoms often beginning in the late teen years and early twenties for men and the late twenties and early thirties for women.²

Schizophrenia may result from changes in certain naturally occurring brain chemicals, such as dopamine and glutamate. Other risk factors may include family history, certain life experiences (eg, stress, danger), or taking psychoactive or psychotropic drugs as a teen or young adult.²

Risperidone is an atypical antipsychotic medication initially approved for various conditions, including schizophrenia in adults and children aged 13 years and older, bipolar I disorder with acute manic or mixed episodes in adults and children aged 10 years and older, and autism-associated irritability in children aged 5 years and older. The long-acting injectable formulation of the treatment is specifically approved for the treatment and maintenance of patients with schizophrenia and can be administered as either a monotherapy or adjunctive therapy with valproate or lithium for maintenance of bipolar disorder in adult patients.^1,3

Risperidone's antidepressant effects are believed to involve serotonin and norepinephrine reuptake inhibition, according to experts. Positive symptoms are thought to result from the blockade of D2 receptors in the mesolimbic pathway. The ability of antipsychotics to block D2 receptors in the prefrontal cortex and nucleus accumbens is essential in improving various psychiatric symptoms. Further, this treatment has also been used off-label to treat the following: borderline personality disorder, delusional disorder, delirium, depression, various brain injuries, posttraumatic stress injury, Tourette syndrome, trichotillomania, speech disorders (eg, stuttering), movement disorders, and developmental disorders. Along with psychotic symptoms, risperidone is also prescribed to treat aggression and agitation in patients with dementia, to augment antidepressant therapy for patients with nonpsychotic unipolar depression, and for social impairment, stereotypical behaviors, cognitive problems, and hyperactivity in patients with autism.³

The most common adverse events reported by patients in clinical trials receiving treatment with risperidone extended-release injectable suspension were headache, parkinsonism, dizziness, movement disorder, fatigue, constipation, indigestion, sedation, weight increase, pain in extremity, and dry mouth.¹

“This approval further strengthens our complex injectables portfolio with a new long-acting treatment option in mental health,” Arash Dabestani, PharmD, senior vice president, Institutional. “Risperidone extended-release injectable suspension requires advanced capabilities—such as microsphere formulation and cold-chain manufacturing—that underscore Amneal’s leadership in developing and producing complex medicines. This milestone reflects our strong [research and development] and manufacturing expertise and lays the foundation for future microsphere-based long-acting injectables.”¹

REFERENCES

1. GlobeNewswire. Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension. News release. September 4, 2025. Accessed September 4, 2025. https://www.globenewswire.com/news-release/2025/09/04/3144952/0/en/Amneal-Receives-U-S-FDA-Approval-for-Risperidone-Extended-Release-Injectable-Suspension.html

2. Mayo Clinic. Schizophrenia. Accessed September 4, 2025. https://www.mayoclinic.org/diseases-conditions/schizophrenia/symptoms-causes/syc-20354443

3. McNeil SE, Gibbons JR, Cogburn M. Risperidone. National Library of Medicine — National Center for Biotechnology Information. Updated November 10, 2024. Accessed September 4, 2025. https://www.ncbi.nlm.nih.gov/books/NBK459313/