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
Teva reported third quarter revenues of $4.5 billion, an increase of 3 per cent year-over-year.
Cobenfy generated $43 million in third-quarter sales, up from $35 million in the second quarter
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
No post-injection Delirium/Sedation Syndrome (PDSS) observed through 56 weeks
Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy
Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and related psychotic disorders
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
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