Helping to extend Seroquel’s existing reach, AstraZeneca, its maker, has received U.S. Food and Drug Administration (FDA) approval to market it as an effective treatment not only for mania associated with bipolar disorder, but also now for depressive episodes in bipolar disorder too. According to the Reuters report on the news:
The green light from the Food and Drug Administration makes Seroquel XR the first medication cleared in the United States for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder.
Seroquel was first approved for the treatment of schizophrenia in 1997 by the FDA, and for manic episodes of bipolar disorder in 2004. The government-funded CATIE trials demonstrated mixed efficacy for Seroquel. Such research has called into question the effectiveness of such atypical antipsychotic medications versus both placebo and cheaper antipsychotics.
I haven’t had time to look at the research that backs this extended use of Seroquel (the generic name is quetiapine fumarate), but if the FDA approved it, they at least had some data to back this extended use. Given that Seroquel is AstraZeneca’s second biggest drug, the company will go to great lengths to ensure it continues producing big revenues for the company. Extending its approved uses goes a long way to help ensure Seroquel’s continued market dominance.
If you’re taking Seroquel, what this additional approval means is that your doctor may very well keep you on the medication longer-term, no matter what type of episode (manic or depressive) that you may be experiencing. This may make issues like keeping track of one’s medication a little bit simpler.
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Last reviewed: By John M. Grohol, Psy.D. on 12 Oct 2008
Published on PsychCentral.com. All rights reserved.
Grohol, J. (2008). Seroquel XR Gets Additional Approvals. Psych Central. Retrieved on March 12, 2014, from http://psychcentral.com/blog/archives/2008/10/12/seroquel-xr-gets-additional-approvals/