Equetro OK'd for
Bipolar Disorder
(December 13, 2004) -- The U.S. Food and Drug Administration has approved the
Shire Pharmaceuticals drug Equetro (extended release
carbamazepine) for
acute manic episodes associated with
bipolar
disorder, the company announced Monday.
A Shire statement recounting patient trials said the drug produced no
clinically significant weight gain or changes in blood glucose, two side effects
of similar medications. Elevated blood glucose is a risk factor for diabetes.
Bipolar disorder, characterized by mood swings of
mania and
depression and periods of normal mood in between, affects some 2 million
American adults annually, the company said. Also known as manic depression, the
condition ranks among the top six mental disorders worldwide, Shire said, citing
the World Health Organization.
The drug is expected to hit the U.S. market in the first quarter of 2005, the
company said.
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