FDA Draft Guidance Seeks to Improve Drug Abuse, Dependence Information in Labeling
The FDA is looking to make the information in the Drug Abuse and Dependence section of product labeling more consistent and clear through a new draft guidance.
All articles by Diana Ernst, RPh
Review Investigates Adverse Effects of Cannabidiol
The use of cannabidiol (CBD), the non-intoxicating component of cannabis, has been associated with numerous adverse effects based on available evidence from animal and human studies.
Adhansia XR Soon to Be Available for ADHD
Adhansia XR (methylphenidate HCl extended-release capsules) is expected to be available as of July 15, 2019 for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older, according to Adlon Therapeutics.
DEA Schedules Postpartum Depression Treatment Zulresso
The Drug Enforcement Administration (DEA) has placed Zulresso (brexanolone; Sage Therapeutics), a treatment for postpartum depression, into Schedule IV of the Controlled Substances Act.
Novel Treatment for Schizophrenia Gets FDA’s Breakthrough Therapy Designation
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to SEP-363856 (Sunovion), an investigational treatment for schizophrenia. SEP-363856 is believed to work by activating trace amine-associated receptor 1 (TAAR1) in addition to 5-HT1A receptors; unlike other antipsychotics, this novel agent does not bind to D2 or 5-HT2A receptors. The Breakthrough Therapy designation was…
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