Aripiprazole Depot: Recommendation for Market Authorization in Europe

On September 19th, 2013, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a recommendation for market authorization of aripiprazole depot to the EU Commission. Therefore, approval is to be expected  later this year. The FDA approved the depot preparation of aripiprazole as Abilify Maintena® as early as on February 28th, 2013, in the U.S. it is already available. In Europe, it is not realistic to expect market entry before mid-2014. Continue reading

New Antidepressant: Vortioxetine Approved in the U.S.

On September 30th, 2013, the U.S. Food and Drug Administration (FDA) approved vortioxetine (Brintellix ®; previously Lu AA21004) for the treatment of depressive disorders. Approval from the European Medicines Agency (EMA) was requested in September 2012. Thus, approval in the EU can be expected soon. The substance was also assessed for the treatment of Generalized Anxiety Disorder (GAD). Vortioxetine is marketed by Takeda and Lundbeck. Continue reading