September 2022 Report

September 2022 Report

New Drug and First Time Generic Report

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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

On Sept. 9, 2022, the FDA approved Zydus Pharmaceuticals’ cariprazine capsules, an AB-rated generic to AbbVie’s Vraylar®. The atypical antipsychotic is taken once each day to treat schizophrenia and bipolar I disorder. In a press release, Zydus indicated that it will share 180-day exclusivity for all four strengths of the capsules, but additional companies that will introduce generics to the U.S. market have not yet been identified. No launch date or cost are immediately available.

Impact to Workers’ Comp

Vraylar would most likely be utilized in workers’ compensation as an off-label adjunct to antidepressant therapy for use in major depressive disorder. For any questions about the use of Vraylar, depression medications, 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
Cariprazine (Vraylar®) Antipsychotic Schizophrenia & Bipolar I Disorder Generic approved September 2022.
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

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.

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