MONDAY, March 23, 2009 (HealthDay News) -- The bipolar depression drug Symbyax (fluoxetine hydrochloride; olanzapine) has received U.S. Food and Drug Administration approval as a therapy for people with treatment-resistant depression, Eli Lilly & Co. said Monday.
The approval applies to adults who haven't responded to two separate rounds of therapy with different antidepressants, the Indianapolis Business Journal reported.
"Living with major depressive disorder is difficult and distressing for anyone, but even more so for patients whose symptoms continue despite treatment," Lilly medical director Dr. Sara Corya said in a company news release. "Now, after two failed attempts with other antidepressants, doctors and patients have a new treatment option."
To get this approval, Lilly had to change the drug label information to include stronger language about the risk of weight gain and diabetes.
Symbyax, a combination of Lilly's drugs Zyprexa and Prozac in one pill, was approved by the FDA to treat bipolar depression in 2003, the Indianapolis Business Journal reported.
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