Caplyta is indicated for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorders, as monotherapy and as adjunctive therapy with lithium or valproate.
Schizophrenia
FDA Delays Decision on Long-Acting Schizophrenia Treatment, Issues CRL
The CRL states that the application cannot be approved in its current form.
Igalmi Sublingual Film Approved for Agitation With Schizophrenia, Bipolar Disorder
The approval was based on data from the phase 3 SERENITY I and II studies that evaluated Igalmi for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, respectively.
New Drugs Approved in 2021
Visit our New Drug Products page to stay up-to-date on the latest drug approvals.
Rexulti Approval Expanded to Include Adolescents With Schizophrenia
The approval was based on data from an ongoing phase 3 trial evaluating the safety and tolerability of brexpiprazole as maintenance treatment of 194 patients aged 13 to 17 years with schizophrenia.
Lybalvi Now Available for Schizophrenia, Bipolar I Disorder
Lybalvi is an atypical antipsychotic comprised of samidorphan co-formulated with olanzapine in a single bilayer tablet.
Invega Hafyera Approved for Twice-Yearly Treatment of Schizophrenia
The Food and Drug Administration has approved Invega Hafyera™ (paliperidone palmitate), an every 6-month injection, for the treatment of schizophrenia in adults. Invega Hafyera is a long-acting atypical antipsychotic that is administered as a gluteal intramuscular injection by a health care professional. Prior to initiating treatment with Invega Hafyera, patients must have been adequately treated…
Application for Long-Acting Schizophrenia Treatment Accepted for Review
Patients treated with the investigational subcutaneous risperidone injection experienced a statistically significant delay in the time to relapse.
MPR Weekly Dose Podcast Episode 88
The FDA authorizes a postexposure prophylaxis for COVID-19; A new treatment is okay’d for lupus; A higher dose naloxone nasal spray became available; The risk evaluation and mitigation program for Clozapine has had important changes, and finally, Istodax has had an indication withdrawn.
