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FDA expands its approval on Symbyax

US regulators have expanded the approval of Eli Lilly's Symbyax for treatment-resistant depression, the company announced on March 23

US regulators have expanded the approval of Eli Lilly's Symbyax for treatment-resistant depression (TRD), the company announced on March 23.

The drug, which combines the active ingredients of its Zyprexa antipsychotic (olanzapine) and Prozac antidepressant (fluoxetine HCI), is the first to be approved by the Food and Drug Administration (FDA) for the acute treatment of TRD.

The new indication applies to adults with a major depressive disorder who have not responded to two separate rounds of therapy with different antidepressants.

"Living with major depressive disorder is difficult and distressing for anyone, but even more so for patients whose symptoms continue despite treatment. Until [now], there has been no approved medication for treatment-resistant depression," said Eli Lilly medical director Dr Sara Corya.

Symbyax has also been approved for the acute treatment of bipolar depression.

Prozac was a Lilly blockbuster until it lost its patent protection. Zyprexa has been one of the company's main growth engines but has recently faced generic competition and concerns that the pill causes weight gain that increases the risk of diabetes.

Eli Lilly has updated its product labels for Zyprexa and Symbyax in line with the Physician's Labelling Rule (PLR) to include information about weight gain, hyperglycaemia and hyperlipidemia. This move, also reported on March 23, follows an FDA review of clinical trial data submitted between August 2007 and July 2008.

24th March 2009


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