The New Drug Application (NDA) for viloxazine hydrochloride (SPN-812; Supernus Pharmaceuticals), a serotonin norepinephrine modulating agent, has been submitted to the Food and Drug Administration (FDA) for the treatment of pediatric patients with attention deficit hyperactivity disorder (ADHD).
The Nonprescription Drugs Advisory Committee (NDAC) of the Food and Drug Administration (FDA) has recommended the approval of the New Drug Application (NDA) from GlaxoSmithKline for an over-the-counter (OTC) nicotine mouth spray to aid in smoking cessation (9 to 6 vote). The nicotine mouth spray (NMS) delivers 1mg nicotine per spray; each dispenser would deliver…
The Food and Drug Administration (FDA) has granted Fast Track designation to ANX005 (Annexon Biosciences) for the treatment of Guillain-Barré Syndrome (GBS), an autoimmune disease that can lead to widespread peripheral nerve damage and paralysis.
