Trials & Filings

Otsuka, Lundeck Monthly Abilify Approved in Europe

IM injection cleared for maintenance treatment of schizophrenia

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Otsuka Pharmaceutical and H. Lundbeck A/S has received marketing authorization approval from the European Commission for Abilify Maintena (aripiprazole), an intramuscular (IM) once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. According to the companies, Abilify Maintena reduces the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia. It has a tolerability profil...

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