The bipolar depression drug Symbyax has received U.S. approval as a therapy for patients with treatment-resistant depression, Eli Lilly & Co. announced Monday.
The FDA approval applies to use in adult patients 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 FDA 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 Lillys drugs Zyprexa and Prozac in one pill, was approved by the FDA to treat bipolar depression in 2003, the Indianapolis Business Journal reported.
In related news, the FDA approved the use of Zyprexa and Prozac, in separate pills, to treat bipolar depression and treatment-resistant depression.