Duloxetine Drug Interactions Are Issue For Yentreve, But Not For Cymbalta
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Review documents for Cymbalta note a difference in opinion regarding the significance of drug interactions between FDA’s review divisions for the two duloxetine indications – major depressive disorder and stress urinary incontinence (under the trade name Yentreve).
You may also be interested in...
Cymbalta Liver Safety Was Key Review Issue Delaying Lilly’s Antidepressant
Initial approval of Lilly’s Cymbalta appears to have been delayed primarily by concerns over liver toxicity, FDA review documents for the serotonin-norepinephrine reuptake inhibitor show.
Cymbalta Liver Safety Was Key Review Issue Delaying Lilly’s Antidepressant
Initial approval of Lilly’s Cymbalta appears to have been delayed primarily by concerns over liver toxicity, FDA review documents for the serotonin-norepinephrine reuptake inhibitor show.
FDA Has 19 Applications Remaining With User Fees In 2004: 7 NMEs, 1 BLA
With seven first-cycle new molecular entities with user fee deadlines in November and December, FDA could surpass the total number of new molecular entities approved in 2003.