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Article: FDA Approves ABILIFY(TM) (Aripiprazole) Supplemental New Drug Application (sNDA) for Maintaining Stability in Patients With Schizophrenia; - Efficacy, Safety and Tolerability of ABILIFY Was Maintained for Up to 26 Weeks in Placebo-Controlled Study -.
- Article from:
- PR Newswire
- Article date:
- September 8, 2003
CopyrightCOPYRIGHT 2003 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (U.S. FDA) approved a Supplemental New Drug Application (sNDA) for ABILIFY(TM) (aripiprazole) for maintaining stability in patients with schizophrenia.
"Because schizophrenia is a chronic illness that requires ongoing treatment, it is important for physicians, consumers and family members to have information regarding the longer-term use of medication," said Dr. Peter Weiden, Director of the Schizophrenia Research Program and Professor of Psychiatry, SUNY Downstate Medical Center. "These data demonstrate that ABILIFY is efficacious in the ...
<23: Placebo-treated patients had a mean weight
change from baseline of -0.5 kg (-1.10 lbs) and 3.7% of patients
experienced a>
<23; +1.4 kg (+3.08 lbs) and 19% in patients with BMI 23-27; and -1.2 kg (-2.64 lbs) and 8% in patients with BMS>