OTSUKA RECEIVES COMPLETE RESPONSE LETTER FOR EXTENDED-RELEASE INJECTABLE SUSPENSION OF ARIPIPRAZOLE
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced receipt of a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) to the New Drug Application (NDA) for the investigational intramuscular (IM) depot formulation of aripiprazole. In the letter, the only issue FDA cited was deficiencies from a recent inspection of a third-party supplier of sterile water.
Otsuka is working closely with the third-party supplier to resolve the issue as quickly as possible and is planning further discussions with the agency to determine next steps.
The content of this release will have no influence on the Lundbeck Group's financial guidance for 2012, which was provided on 8 February 2012 in connection with the release of the financial results for 2011, and further specified in connection with the announcement of the restructuring plan on 14 June 2012.