Archive for October, 2008

Market Wire - Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration

Wednesday, October 29th, 2008

Eli Lilly and Company (NYSE: LLY) has
submitted a supplemental New Drug Application (sNDA) to the U.S. Food and
Drug Administration (FDA) seeking approval for a new indication for
Cymbalta (duloxetine HCl) for the management of chronic pain, the
company announced today. The submission is based on outcomes of clinical
trials in chronic osteoarthritis pain of the knee and chronic low back
pain, in addition to data from previously completed pain studies in
diabetic peripheral neuropathi…

Business Wire - FDA Issues Second Approvable Letter for Lilly’s Cymbalta for the Treatment of Depression

Tuesday, October 28th, 2008

Business Editors/Health/Medical Writers
INDIANAPOLIS–(BUSINESS WIRE)–Oct. 1, 2003
No Additional Studies Required before Approval; Final Approval
Contingent upon Resolution of Manufacturing Issues and Completion of
Label Negotiations
The U.S. Food and Drug Administration issued a second approvable letter for Cymbalta(TM) (duloxetine HCl; pronounced SIM-BALL-TA), a potent serotonin and norepinephrine reuptake inhibitor, Eli Lilly and Company (NY…

HealthDay - Cymbalta Approved for Fibromyalgia

Thursday, October 23rd, 2008

Eli Lilly said Monday that its antidepressant Cymbalta (duloxetine) has been approved by the U.S. Food and Drug Administration to treat fibromyalgia, a chronic disorder with symptoms including widespread muscle pain and tenderness.
The condition affects about 2 percent of the American population, or about 5 million people, mostly women. While its cause is unknown and there is no known cure, it’s believed it may be related to a combination of changes in brain…

PR Newswire UK Disclose - LILLY (ELI) & COMPANY - LLY - Data Suggests Cymbalta(R) GAD APA.

Saturday, October 18th, 2008

Related Results

Lilly prepares for Cymbalta launch

Duloxetine lifts arthritis pain, aids cognition.(Psychosomatic Medicine)

PR Newswire - FDA Approves Cymbalta® for the Management of Fibromyalgia

Sunday, October 12th, 2008

Cymbalta Reduces Pain and Improves Functioning in Fibromyalgia Patients
INDIANAPOLIS, June 16 /PRNewswire-FirstCall/ — The U.S. Food and Drug Administration (FDA) has approved Cymbalta(R) (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company announce…

PR Newswire UK Disclose - LILLY (ELI) & COMPANY - FDA Approves Cymbalta for Maintenance Treatment.

Tuesday, October 7th, 2008

Date: November 30, 2007

For Release: Immediately

Refer to: Tamara Hull 317-651-9116; mobile: 317-614-5132

FDA Approves CymbaltaA[R] for Maintenance Treatment of Major Depressive Disorder

INDIANAPOLIS - Eli Lilly and Company (NYSE: LLY) announced today that the U.S.
Food and Drug Administration (FDA) has approved CymbaltaA[R] (duloxetine HCl) for
the maintenance treatment of major depressive disorder (MDD) in adults.

Relat…

New Antidepressant Works Fast

Wednesday, October 1st, 2008

Nov. 11, 2002 — Often, several weeks go by before an antidepressant begins lifting the fog of depressiondepression. But a new drug called Cymbalta seems to offer quicker results — without any noticeable long-term side effects.

In several large studies, presented at the U.S. Psychiatric and Mental HealthMental Health Co…