The Agency reviewed case reports from the FAERS database and calls from US poison control centers related to systemic symptoms after applying alcohol-based hand sanitizers to the skin.
Zuranolone is an investigational 2-week, once-daily oral treatment for adults with major depressive disorder.
The system works with Medtronic’s Percept™ PC Neurostimulator.
The approval was based on safety and efficacy data from a study that included 425 patients 18 months through 5 years of age.
The approval was based on data from 27 clinical studies, including the phase 3 ENLIGHTEN-1 and ENLIGHTEN-2 studies.
Qelbree is a selective norepinephrine reuptake inhibitor.
The designation is based on results from a phase 2 trial that evaluated the efficacy and safety of 4 different doses of BI 425809 orally once daily in adults with CIAS for 12 weeks.
In both trials, BXCL501 demonstrated statistically significant, rapid and durable improvements vs placebo across multiple agitation scales.
The sNDA submissions are supported by data from 2 global randomized, double-blind, placebo-controlled phase 3 studies.
Kloxxado is intended for immediate administration as emergency therapy in settings where opioids may be present.
