Brintellix Review To Focus On Cognitive Function Measurement
This article was originally published in The Pink Sheet Daily
Executive Summary
Takeda's request for novel claim for an antidepressant hinges on FDA acceptance of clinical outcomes assessment used in vortioxetine's trials, but agency raises doubts about utility of results.
You may also be interested in...
Brintellix Label Gives Lundbeck Ground For Tolerability Claims
Lundbeck/Takeda’s newly approved antidepressant Brintellix is poised to enter the crowded, genericized antidepressant market at the end of 2013. Potential advantages in labeling include flexible dosing, lack of weight gain and lower rates of sexual dysfunction compared to some other drugs.
US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios
Forthcoming guidance is expected to describe areas of “low-hanging fruit” and those that are more challenging for use of the expedited pathway, Center for Biologics Evaluation and Research Director Peter Marks said.
Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works
FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.