The sNDA submission was supported by data from the pivotal phase 3 HARMONY study.
The approval was based on data from an extensive development program that included four phase 3 studies involving more than 1000 patients 6 to 17 years of age with ADHD.
The FDA has accepted for review the NDA for daridorexant, an investigational dual orexin receptor, for the treatment of insomnia in adults.
Azstarys consists of serdexmethylphenidate, a prodrug of dexmethylphenidate, co-formulated with immediate-release dexmethylphenidate.
The sNDA submissions are supported by data from 2 global randomized, double-blind, placebo-controlled phase 3 studies.
While the use of TIRF medications has declined in recent years, data have suggested that prescribing of these drugs to patients who are not opioid tolerant still remains.
Benzodiazepines are widely used to treat a variety of conditions including anxiety disorders, insomnia and seizures.
The 510(k) clearance allows for modification of the labeling of the previously authorized pharmacogenetics report.
Naloxone is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose.
The approval was based on the ASPIRE I and II trials that compared the efficacy and safety of esketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, to placebo in 449 adults with moderate to severe MDD who had active suicidal ideation and intent.
