Lilly, Boehringer Ingelheim Withdraw NDA for Duloxetine to Treat SUI

Eli Lilly and Boehringer Ingelheim Pharmaceuticals have jointly announced that Lilly has withdrawn from the FDA's Division of Reproductive and Urologic Drug Products its new drug application for duloxetine hydrochloride for the treatment of stress urinary incontinence (SUI).

This decision was based on discussions with the FDA suggesting the agency is not prepared at this time to grant approval for duloxetine for the treatment of the SUI patient population based on the data package submitted. The companies will evaluate all options for next steps once they have had time to fully understand the FDA's perspective.

Ongoing clinical trials for duloxetine SUI will continue. This action does not affect the marketing status of duloxetine for the indications of depression and diabetic peripheral neuropathic pain in the U.S. or the SUI and depression indications outside the U.S.