PRINCETON, N.J., July 28, 2024 /PRNewswire/ -- Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sales of innovative medications, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's ERZOFRI® (paliperidone palmitate) extended-release injectable suspension, for treating schizophrenia in adults and for treating schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.
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The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation in Britain for the long-acting atypical antipsychotic therapy Byannli–the six-monthly paliperidone palmitate (PP6M)–for the maintenance treatment of schizophrenia in adult patients.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the approval of the long-acting atypical antipsychotic therapy Byannli (6-monthly paliperidone palmitate; PP6M) by the European Commission (EC) for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1-monthly paliperidone palmitate (PP1M) or 3-monthly paliperidone palmitate (PP3M).
Johnson & Johnson have announced the approval of the long-acting natypical antipsychotic therapy BYANNLI® by the European Commission (EC),nfor the maintenance treatment of schizophrenia in adult patients who nare clinically stable on 1-monthly paliperidone palmitate (PP1M) or 3 nmonthly paliperidone palmitate (PP3M). This approval makes PP6M the nfirst twice-yearly treatment for adults living with schizophrenia to be napproved by the EC, with the longest available dosing interval for an nantipsychotic medication in the European Economic Area.
BEERSE, Belgium--(BUSINESS WIRE)--The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending the long-acting atypical antipsychotic therapy BYANNLI® (6-monthly paliperidone palmitate; PP6M) for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1-monthly paliperidone palmitate (PP1M)2 or 3-monthly paliperidone palmitate (PP3M).3 If approved by the European Commission, PP6M will provide the first twice-yearly treatment for adults living with schizophrenia and longest available dosing interval for an antipsychotic medication in the European Economic Area.1,4
TITUSVILLE, N.J., Sept. 1, 2021 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic INVEGA HAFYERA™ (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. Before transitioning to INVEGA HAFYERA™, patients must be adequately treated with INVEGA SUSTENNA® (1-month paliperidone palmitate) for at least four months, or INVEGA TRINZA® (3-month paliperidone palmitate) for at least one 3-month injection cycle.1