FDA issues Complete Response Letter relating to Abilify Depot (Otsuka/Lundbeck) for monthly treatment of Schizophrenia - 03-Aug-2012

Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. have announced receipt of a Complete Response Letter from the FDA to the New Drug Application (NDA) for the investigational intramuscular (IM) depot formulation of Abilify (aripiprazole). In the letter, the only issue FDA cited was deficiencies from a recent inspection of a third-party supplier of sterile water.

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