Bristol-Myers Squibb Company and
Otsuka Pharmaceutical Co., Ltd., have announced that the FDA has approved
ABILIFY(R) (aripiprazole) as an adjunct to the mood stabilizers lithium or
valproate for the maintenance treatment of Bipolar I Disorder.

ABILIFY was
approved as an adjunct to lithium or valproate for the acute treatment of manic
or mixed episodes associated with Bipolar I Disorder in May 2008. ABILIFY is
also approved as monotherapy for the acute treatment of manic or mixed episodes
associated with Bipolar I Disorder and for the maintenance treatment of Bipolar
I Disorder.

ABILIFY has a
boxed warning regarding increased mortality in elderly patients with
dementia-related psychosis. Elderly patients treated with antipsychotic drugs
are at an increased risk of death. ABILIFY is not approved for the treatment of
patients with dementia-related psychosis.

“Patients
with Bipolar I Disorder often experience cycles of severe mood swings rather
than a single episode1,” said John Tsai, M.D., vice president, U.S.
Medical, Bristol-Myers Squibb. “Because Bipolar Disorder is a lifelong and
recurrent illness, this labeling update provides physicians with the option to
prescribe ABILIFY as an add-on to either lithium or valproate as a long-term
treatment to help manage symptoms of Bipolar I Disorder. Patients should be
periodically reassessed by their physician to determine the continued need for maintenance
treatment.” “Otsuka remains committed to developing products that are
able to meet their fullest potential while helping physicians provide effective
care for their patients,” said William H. Carson, M.D., President and CEO,
Otsuka Pharmaceutical Development and Commercialization, Inc. “By updating
the label to include maintenance treatment with ABILIFY as an add-on to lithium
or valproate for patients with Bipolar I Disorder, we are helping to provide
more options to physicians.”