FDA approves Teva’s expanded indication for Uzedy for bipolar I disorder
UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for use every one or two months for the treatment of schizophrenia in adults
UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for use every one or two months for the treatment of schizophrenia in adults
Divalproex Sodium Extended-Release tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches
The move puts a spotlight on one of psychiatry’s most persistent clinical challenges: misdiagnosis and delay
The company receives approval for blood-based test enabling objective differentiation of schizophrenia and bipolar disorder
The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder
This marks Lupin’s first commercial product leveraging PrecisionSphere, a proprietary long-acting injectable (LAI) technology
The results demonstrated meaningful reductions in the severity of involuntary movements and notable improvements in patient-reported quality of life
This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials
Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and related psychotic disorders
KarXT, Karuna’s lead asset, is a potential first-in-class treatment for Schizophrenia
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