Parker Waichman LLP

Eli Lilly Withdraws Cymbalta Application

Eli Lilly and Company has announced that it withdrew an application to market Cymbalta as a treatment for chronic pain.  Reuters is reporting that the application to expand the approved uses of Cymbalta, already approved as an anti-depressant, faced questions from U.S. health regulators over efficacy and dosage recommendations. Lilly said its move to pull […]

Eli Lilly and Company has announced that it withdrew an application to market Cymbalta as a treatment for chronic pain.  Reuters is reporting that the application to expand the approved uses of <"https://www.yourlawyer.com/topics/overview/cymbalta">Cymbalta, already approved as an anti-depressant, faced questions from U.S. health regulators over efficacy and dosage recommendations.

Lilly said its move to pull the supplemental New Drug Application (NDA) for Cymbalta—known generically as duloxetine HCl—was prompted by  FDA reviewers’ questions regarding  “the design of supporting Lilly studies and statistical methodology,” said Reuters.  The report said that Lilly plans to resubmit its application in early 2009, “after adding data from a recently completed study in chronic osteoarthritis pain of the knee.”

The recent decision does not affect Cymbalta’s current FDA-approval for the drug’s use for major depressive disorder, generalized anxiety disorder (DAD), management of diabetic peripheral neuropathic pain, and management of fibromyalgia, Lilly told Reuters.

As an antidepressant, Cymbalta has raised safety concerns. When the FDA issued a  prior warning about the potential for suicidal thinking in adults taking antidepressants, it specifically singled out Cymbalta because of a higher than expected suicide attempt rates revealed in studies.  Cymbalta has been associated with suicide risk since its clinical trials and one review of Cymbalta found that 11 of nearly 9,000 women taking it for urinary incontinence tried to commit suicide. The fact that these patients were suffering from urinary incontinence and not depression is significant because the drug companies have long argued that antidepressants are used by depressed people who experience a higher likelihood of committing suicide.

Concerns about suicidal behavior surfaced in 2004 when  Traci Johnson, a healthy volunteer involved in a trial at Eli Lilly’s clinic at Indiana University Medical Center in Indianapolis, killed herself in one of the clinic’s showers.  Johnson, who did not suffer from depression, was taken off the drug and given a placebo four days before she hung herself in one of the clinic’s showers.  She was the fifth patient to commit suicide after taking Cymbalta in clinical trials. After her death, one-fifth of the volunteers quit the Cymbalta trial.

The FDA began reanalyzing hundreds of studies of the drugs and told makers to add or strengthen suicide-related warnings on their labels in the meantime.  Since then, several new studies have been published in medical journals about a possible connection with suicidal behavior.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Aubrey Kendall
6 years ago
5 Star Reviews 150
My husband lost his parents within 2 years. His father most recently and we are distraught over his care prior to passing. We decided to call Parker Waichman, and were greeted by Joanna. We sat and explained our story, and literally felt like we were sitting with family. Joanna went out of her way to make sure we understood every single detail, and were comfortable with our choices. Lawyers can be intimidating, but we never once felt that way. We are very comfortable with our choice to use them and would recommend anyone to use their services. (Joanna even went out of her way to hand deliver the most delicious olive oil, not sold in the U.S to our home!!)
Diane Terracciano
3 years ago
5 Star Reviews 150
To the employees Ana, Jorge & Jillian. I am very thankful for the effort that they did all this time in my case, they are helpful people and they take their job seriously. Thank You regards Jose Aguaiza.
franklin orlando
8 months ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038