August 5, 2009 — The US Food and Drug Administration (FDA) has approved a long-acting, once-monthly formulation of paliperidone palmitate injection (Invega Sustenna, Janssen, a division of ...

On August 23, 2022, the Federal Court issued its public judgment and reasons in two actions under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (the “Regulations”) ...

If approved, paliperidone palmitate 3-monthly injection will be the first once-every-three-months treatment for schizophrenia in the UK Janssen UK announced today that the Committee for Medicinal ...

Results served as basis for regulatory filing with U.S. Food and Drug Administration and designation as Priority Review TITUSVILLE, N.J., March 29, 2015 /PRNewswire/ -- Three-month paliperidone ...

Janssen R&D announced that the Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate to treat ...

TITUSVILLE, N.J., March 29, 2015 /PRNewswire/ -- Three-month paliperidone palmitate, an investigational atypical antipsychotic, significantly delayed time to relapse compared to placebo in patients ...

With respect to tolerability concerns with the recommended paliperidone palmitate initiation dosing, this study did not reveal unexpected adverse events or high rates of specific adverse events in the ...

Janssen R&D announced that it has submitted a New Drug Application (NDA) to the FDA, for three-month paliperidone palmitate as treatment for schizophrenia in adults. The NDA submission is based on a ...

The extended-release delivery coupled with the 351mg dose allows for single-dose initiation. Erzofri ® (paliperidone palmitate) extended-release injectable suspension is now available for the the ...

BEERSE, Belgium--(BUSINESS WIRE)--The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a Marketing Authorisation Extension Application to the European Medicines Agency (EMA) to register ...

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On May 5, 2020, Manson J. of the Federal Court issued the second decision on the merits under the amended Patented Medicines (Notice of Compliance Regulations). The Court upheld the validity of ...