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Zuranolone is a rapid-acting neuroactive steroid that can take effect in 14 days to treat patients with major depressive disorder and postpartum depression. The FDA has assigned a PDUFA action date of Aug. 5, 2023.

FDA Accepts NDA for Zuranolone for Depression

This is the fourth indication for Vraylar, a dopamine and serotonin partial agonist that can now be used as an adjunctive therapy in patients with major depressive disorder.

FDA Approves Vraylar for Major Depressive Disorder

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

EmpiRx Health CEO Karthik Ganesh discusses how the PBM was able to decrease mental health drug spending at a time when utilization is increasing.

EmpiRx Health Lowers Drug Spend in Mental Health

Aripiprazole, currently available as a once-monthly injection under the brand name Abilify Maintena, is being reviewed as a two-month therapy. The FDA target date for completion of the review is April 27, 2023.

FDA Accepts NDA for Longer-Acting Aripiprazole

Axsome anticipates Auvelity to be commercially available in the fourth quarter of 2022.

FDA Approves Rapid-Acting Auvelity for Major Depression

A clinical trial showed Dyanavel XR tablets were bioequivalent to the extended-release oral suspension formulation of Dyanavel.

Tris Pharma Launches Dyanavel XR Tablets for ADHD

Doug Nemecek, M.D., chief medical officer, behavioral health at Evernorth, talks about the mental health issues teenagers are facing.


COVID-19’s Impact on Teenagers’ Mental Health

The Psychopharmacologic Drugs Advisory Committee will meet on June 17, 2022; the PDUFA date is August 4, 2022.

FDA Schedules Advisory Committee for Nuplazid in Alzheimer’s Psychosis

Dr. Caroline Carney of Magellan Healthcare discusses the psychedelics in the pipeline for treating mental health conditions.

Can Psychedelics Treat Mental Health Conditions?

The new code will be effective April 1, 2022.

Psychiatry and Behavioral Health