Eli Lilly has withdrawn its supplemental New Drug Application (sNDA) from the USFDA for Cymbalta (duloxetine HCl) for the management of chronic pain. Lilly thinks of resubmitting the application in the first half of 2009 following the addition of data from a recently completed positive study in chronic osteoarthritis pain of the knee. Withdrawl of the application will affect duloxetine's FDA-approved indications for major depressive disorder, generalized anxiety disorder, management of diabetic peripheral neuropathic pain and management of fibromyalgia.
No comments:
Post a Comment