August 2022 Report

August 2022 Report

New Drug and First Time Generic Report

Download Report

Monthly update of U.S. Food and Drug Administration (FDA) approvals impacting the workers' compensation industry. myMatrixx's report includes new drug and indication approvals, discontinuation and withdrawals, new dosages or formulations of existing products and newly available generics in the last 12 months.

Monthly Drug News

The U.S. Food and Drug Administration (FDA) approved Auvelity™ extended-release tablets on August 18, 2022. Indicated to treat adults who have major depressive disorder (MDD), it combines 45 mg of dextromethorphan, which is an N-methyl D-aspartate (NMDA) receptor inhibitor, with 105 mg of bupropion, which interferes with the activity of certain blood components. The result is higher blood levels of dextromethorphan and a longer duration of its effectiveness. In contrast to other current oral antidepressants, which may take several weeks to reach full effectiveness, Auvelity acts more quickly. In clinical studies comparing it to either placebo or bupropion, alone, it showed more positive effects at one week after the first dose and effectiveness lasted over the six-week long study periods.

Auvelity was approved under the FDA’s Breakthrough Therapy and Priority pathways. Its launch is planned for the fourth quarter of 2022, but the price is not yet determined.

Impact to Workers’ Comp

While depression isn’t the most common indication in workers’ compensation, any new antidepressant has the potential to impact a compensable claim. For any questions about the use of Auvelity, antidepressants, and potential relatedness to a claim, please consult with your myMatrixx pharmacist.

New Brand Drug Pipeline

Medication (Brand name) Drug Class Therapeutic Use Status Update
Bupropion/Dextromethorphan (Auvelity™) Antidepressant Major Depressive Disorder Launch pending. Approved August 18, 2022.
Buprenorphine Depot Injection (Brixadi™) Opioid Agonist Treatment of
Opioid Addiction
FDA review pending.
Oxycodone (Aximris XR™) Opioid Analgesic –
Extended Release
Pain FDA review pending.


NSAID/Serotonin Agonist

Migraine Headache FDA review pending.

Generic Pipeline

Medication (Brand name) Drug Class Therapeutic Use Status Update
Oxycodone HCl (Oxaydo®) Opioid Agonist Pain Generic exclusivity anticipated in 2022.
Apixaban (Eliquis®) Anticoagulant Treatment/Prophylaxis of Deep Vein Thrombosis Generics approved December 23, 2019, but settlements expected to delay launch for at least a few years.

Available in the Last 12 Months

Medication (Brand name) Drug Class Therapeutic Use Status Update
Nalmefene Injection Opioid Antagonist Opioid Overdose June 2022
Baclofen Granules (Lyvispah®) Muscle Relaxant Muscle Spasticity June 2022
Naloxone Injection (Zimhi™) Opioid Antagonist Opioid Overdose March 2022
Celecoxib/Tramadol (Seglentis®) NSAID/Opioid Agonist Pain March 2022
Baclofen Oral Suspension (Fleqsuvy™) Muscle Relaxant Muscle Spasms March 2022
Celecoxib Oral Liquid (Elyxyb™) NSAID Migraine Headache Treatment February 2022

Newly Available Generics

Medication (Brand name) Drug Class Therapeutic Use Status Update
Dabigatran (Pradaxa®) Anticoagulant Deep Vein Thrombosis June 2022
Vilazodone (Viibryd®) Antidepressant Depression June 2022
Diclofenac Sodium 2% (Pennsaid®) Solution Topical NSAID Pain May 2022

Diclofenac Potassium (Zipsor®) Capsule

NSAID Pain March 2022
Naloxone HCl (Narcan®) Nasal Spray Opioid Antagonist Opioid Overdose December 2021
Zolmitriptan Nasal Spray (Zomig®) Serotonin Agonist Migraine Headache Treatment November 2021
Nebivolol (Bystolic®) Beta Blocker Beta Blocker September 2021

Discontinuations & Withdrawals

Medication (Brand name) Drug Class Therapeutic Use Status Update
Hydrocodone ER Capsules (Zohydro® ER) Opioid Agonist Pain Manufacturer has stopped distribution and FDA has rescinded approval effective February 2022.

Download Report