Caroline O. Pardo, Ph.D., General Manager for Haymarket Medical Education, is pleased to announce that HME, based in Paramus, NJ, has been accredited as a provider of interprofessional continuing education by the Accreditation Council for Continuing Medical Education, the Accreditation Council for Pharmacy Education, and the American Nursing Credentialing Center.
The FDA has granted Orphan Drug designation to reldesemtiv (Cytokinetics) for the treatment of amyotrophic lateral sclerosis.
The Food and Drug Administration (FDA) has granted Orphan Drug Designation to zotiraciclib (Adastra Pharmaceuticals) for the treatment of glioma.
The FDA has granted Breakthrough Device designation to the RightEye Vision System, a device that measures and analyzes involuntary eye movements to aid in the assessment of Parkinson disease.
The FDA has accepted for filing and granted Priority Review to the New Drug Application (NDA) for Fintepla (low-dose fenfluramine oral solution; Zogenix) for the treatment for seizures associated with Dravet syndrome.
The product was approved in May based on data from the phase 3, placebo-controlled ARTEMIS 1 trial that evaluated the safety and efficacy of the intranasal benzodiazepine in 292 patients.
Sunovion has resubmitted the NDA for apomorphine sublingual film for the treatment of OFF episodes experienced by patients with Parkinson disease.
The Food and Drug Administration (FDA) has granted Fast Track designation to an investigational intranasal formulation of racemic ketamine for the potential treatment of acute suicidal ideation and behavior in patients with major depressive disorder.
The Food and Drug Administration (FDA) has approved the Senza Omnia Spinal Cord Stimulation (SCS) System (Nevro) for the treatment of chronic intractable pain of the trunk and/or limbs.
Apadaz (benzhydrocodone and acetaminophen immediate-release tablets) and its authorized generic AG-Apadaz will be available nationally beginning in November 2019.
