Novartis Focalin XR Extended-Release ADHD Therapy Will Launch In June
This article was originally published in The Pink Sheet Daily
The May 26 Focalin XR approval marks Novartis’ first ADHD treatment indication in adults. The NDA was supported by two clinical trials, one in adults and one in children.
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The approval includes 2.5 mg, 5 mg and 10 mg formulations of dexmethylphenidate tabs for ADHD.
The company said it will update investors on the path forward for zuranolone in major depressive disorder after finalizing discussions with the US FDA. It would not confirm if a meeting had taken place yet.