Kybella Clinical Development Timeline
Executive Summary
Chronicle of the development and review of Kythera's deoxycholic acid injection for submental fat.
You may also be interested in...
Chin Fat Not A 'Serious Condition' Worthy Of Priority Review, FDA Says
Deoxycholic acid offers safe and effective alternative to 'unapproved and unregulated' pharmacy compounded products, Kythera asserted in unsuccessful bid for shorter review.
Patient-Reported Outcomes Data Earned Kybella A Claim For Emotional Impacts
Labeling for the submental fat treatment includes a sentence about improvements in overall patient-reported satisfaction and self-perceived visual attributes based on questionnaire results from the Phase III trials.
Kythera Claims Kybella Name After Lundbeck Stumbles With Carbella
FDA initially rejected Kythera's preferred brand name as vulnerable to confusion with the proposed name for Lundbeck's epilepsy treatment, which was delayed by a complete response letter.