June 2022 Report

June 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

Accord Pharmaceuticals announced on June 8, 2022, that its vilazodone tablets, 10mg, 20mg and 40mg, are ready to ship in the United States, but pricing was not disclosed. The generic for Viibryd® (Allergan), vilazodone is taken once a day for treating adult patients who have major depression. Other manufacturers have FDA approval for generics, as well, but no information is available about their possible launches. Under a settlement agreement, some of the companies will share 180-day exclusivity.

Impact to Workers’ Comp

While antidepressants may have a role in a workers’ compensation injury, Viibryd has not historically been heavily utilized, so the impact of this new generic will be relatively limited. For any questions about the use of Viibryd, 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
Buprenorphine Depot Injection (Brixadi™) Opioid Agonist Treatment of
Opioid Addiction
FDA review pending.
Oxycodone (Aximris XR™) Opioid Analgesic –
Extended Release
Pain FDA review pending.

Meloxicam/Rizatriptan

NSAID/Serotonin Agonist

Migraine Headache FDA review pending.

Generic Pipeline

Medication (Brand name) Drug Class Therapeutic Use Status Update
Dabigatran (Pradaxa®) Anticoagulant Treatment/Prophylaxis of Deep Vein Thrombosis First patent set to expire December 2021. Generic anticipated June 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
Naloxone Nasal Spray (Kloxxado™) Opioid Antagonist Opioid Overdose August 2021

Newly Available Generics

Medication (Brand name) Drug Class Therapeutic Use Status Update
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
Ibuprofen/Famotidine (Duexis®) NSAID/H-2 Receptor Antagonist Pain/Inflammation August 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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