FDA muddies water for Lundbeck/Otsuka's depot aripiprazole
This article was originally published in Scrip
Executive Summary
The US FDA has issued a complete response letter to Lundbeck and Otsuka Pharmaceutical for their new drug application (NDA) for an intramuscular depot formulation of aripiprazole (Abilify), for the maintenance treatment of adult patients with schizophrenia.