BioCentury
ARTICLE | Clinical News

Abilify Maintena aripiprazole regulatory update

March 11, 2013 7:00 AM UTC

FDA approved once-monthly Abilify Maintena aripiprazole to treat schizophrenia. Otsuka and H. Lundbeck expect to launch the extended-release, intramuscular depot formulation of aripiprazole on March 18. Last July, FDA issued a complete response letter for the NDA, citing deficiencies from an inspection of a third-party supplier of sterile water (see BioCentury, July 30, 2012). The product is also under review in Europe (see BioCentury, Jan. 7). ...