Otsuka and Lundbeck Report the US FDA Acceptance of NDA for Aripiprazole to Treat Schizophrenia and Bipolar I Disorder
Shots:
- The US FDA has accepted the NDA for aripiprazole 2mos. to treat schizophrenia & bipolar I disorder in adults. The PDUFA date for review completion is expected on April 27, 2023
- The NDA was based on the 32wk. bridging trial to evaluate aripiprazole in 266 patients which showed that aripiprazole ready-to-use LAI 960mg was as effective as the 400mg 1mos. dose of aripiprazole & were safe & well tolerated with no new safety issues compared to 1mos. aripiprazole 400mg while delivered & sustained plasma concentrations will be similar to 1mos. LAI
- If approved, aripiprazole 2mos., ready-to-use LAI will be available in 960mg or 720mg prefilled syringe administered as an IM inj. into the gluteal muscle q2mos.
Ref: Businesswire| Image: Otsuka
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