Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) has received the US Food and Drug Administration's (FDA) approval for Invega (paliperidone) extended-release tablets indicated for the treatment of schizophrenia in adolescents aged 12 to 17.
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A six-week randomized, double-blind, placebo-controlled study evaluated the safety and efficacy Invega in schizophrenia patients and showed efficacy in adolescents with the dose range of 3 to 12 milligrams a day.
The study results suggested that Invega was adequately tolerated within the dose range of 3 to 12 milligrams a day.
J&JPRD Neuroscience Global Therapeutic Area head Husseini Manji said this new indication for Invega provides an additional option for clinicians who treat adolescents with schizophrenia and further demonstrates our commitment to helping people with diseases of the brain.
Invega, an atypical antipsychotic medication, was first approved in the US in December 2006 for the treatment of schizophrenia in adults.
Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals markets Invega in the US.
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