Eli Lilly withdraws drug application from USFDA for Cymbalta
Eli Lilly withdraws drug application from USFDA for Cymbalta

Eli Lilly & Co., a global pharmaceutical company and one of the world's largest corporations. has informed that it has withdrawn its new-drug application to the U.S. Food & Drug Administration (USFDA) for Cymbalta.

The pharmaceutical firm plans to resubmit application in the first half of next calendar year with supplementary data from a recently completed study in chronic osteoarthritis pain of the knee.

Cymbalta is indicated for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD). In addition, the drug is also used for the management of neuropathic pain associated with diabetic peripheral neuropathy.

John Hayes, vice president of Lilly Research Laboratories, quoted, “this was a difficult decision, but we believe the updated data package will give the FDA a broader basis for reviewing our application."

Indianapolis-based drug firm said that the decision does not affect the drugs FDA-approved indications for major depressive disorder, generalized anxiety disorder or management of diabetic peripheral neuropathic pain.