PharmaSentry :: Cymbalta

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Cymbalta

Developer:	Eli Lilly and Co.
Chemical Name:	Duloxetine hydrochloride
Drug Class (Type):	Serotonin and norepinephrine reuptake inhibitor (Chemical)
Dose Form:	Capsule
Indication:	Cymbalta is indicated for the treatment of major depressive disorder.
Disease/Medical Usage:	Depressive disorder
Therapeutic Category:	Psychotherapeutic agents
Status:	Approved As of Aug 24, 2004, Cymbalta was launched in the United States for the treatment of major depressive disorder.As of Aug 4, 2004, Cymbalta was approved in the United States for the treatment of major depressive disorder.As of Jun 24, 2004, Cymbalta was awaiting approval in the United States for the treatment of major depressive disorder.As of May 6, 2004, Cymbalta was awaiting approval in the United States for the treatment of major depressive disorder.As of Oct 1, 2003, Cymbalta was awaiting approval in the United States for the treatment of depression.As of Sep 3, 2003, Cymbalta was awaiting approval in the United States for the treatment of depression.As of Aug 20, 2003, Cymbalta was awaiting approval in the United States for the treatment of depression.As of Apr 11, 2003, Cymbalta was awaiting approval in the United States for the treatment of depression.As of Nov 8, 2002, Cymbalta was awaiting approval in the United States for the treatment of depression.On Sep 16, 2002, Eli Lilly and Co. announced that it has received an approvable letter from the U.S. Food and Drug Administration for Cymbalta for the treatment of depression. Approval is contingent upon labeling discussions and resolution of the company's outstanding manufacturing issues.As of May 20, 2002, Cymbalta was awaiting approval in the United States for the treatment of depression.On Jan. 24, 2002, Lilly confirmed in its fourth quarter 2001 financial report that the company had submitted an NDA to the FDA for duloxetine, an investigational dual reuptake inhibitor of both serotonin and norepinephrine being developed for the treatment of depression. Clinical trials suggest that duloxetine's distinctive clinical profile may enable it to address a number of unmet medical needs in the antidepressant market. On Oct 24, 2001, Eli Lilly announced that it has just completed three Phase III trials of Duloxetine for the treatment of depression. Lilly plans to make a duloxetine submission in 2001.As of May 7, 2001, Duloxetine was in Phase III clinical trials in the United States for the treatment of depression.As of Nov. 22, 2000, Duloxetine was in Phase III clinical trials in the United States for the treatment of depression.As of July 21, 2000, Duloxetine was in Phase II clinical trials in the United States for the treatment of depression.As of June 14, 2000, Duloxetine was in Phase II clinical trials in the United States for the treatment of depression.
Geographic Region:	United States
Total Sales for 2009:	Not Specified
Last Updated:	February 13, 2006