Duloxetine NDA Withdrawn For Stress Urinary Incontinence
Eli Lilly and Boehringer Ingelheim have announced that Lilly has withdrawn its New Drug Application for generic duloxetine HCl for the treatment of stress urinary incontinence (SUI). The decision was based on discussions with the FDA, suggesting that the agency was not prepared to grant approval based on the data pack-age submitted. Ongoing clinical trials of duloxetine for SUI are expected to continue.
This action does not affect the marketing status of duloxetine for depression and diabetic peripheral neuropathic pain in the U.S. or for SUI and depression indications outside the U.S.
For the treatment of SUI, duloxetine— marketed as Yentreve® and AriClaim® outside the U.S.—has been granted approval in 27 countries. It has been approved for the treatment of major depressive disorder and diabetic peripheral neuropathic pain under the brand name Cymbalta drug.
