Aripiprazole extended release FDA approved

H. Lundbeck A/S rose in Copenhagen for second day in a row with another marketing approval. This time it was the U.S. FDA granting once-monthly Abilify Maintena (aripiprazole) extended release injectable suspension for the treatment of schizophrenia specifically in relapse prevention. The approval was based on a statistically significant 52-week Phase 3 study reading on time to relapse delay. The dopamine D2 partial agonist product has been developed in a global CNS therapies alliance with Otsuka Pharmaceutical Co., Ltd (TYO: 4578).