March 2023 Report

March 2023 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

The U.S. Food and Drug Administration (FDA) approved Amphastar Pharmaceuticals’ Naloxone Nasal Spray, 4 mg, on March 7, 2023. It was approved as a new formulation, not a generic, because it has a patented delivery device. An opioid agonist, naloxone provides temporary reversal of opioid overdoses in emergency settings. One dose (one spray) of naloxone should be given as soon as an overdose is observed or suspected, based on the patient’s breathing difficulty and/or unconsciousness. Emergency medical help should be requested immediately after the first spray. If needed, one additional spray can be given every two to three minutes until professional assistance arrives. In the U.S., naloxone nasal spray, 4 mg, can be dispensed without a prescription or it can be prescribed for a caregiver of an at-risk patient, depending on state regulations.

Naloxone nasal spray, 4 mg, is available as the branded drug, Narcan® and in generic forms. A higher strength formulation, Kloxxado® (naloxone nasal spray, 8 mg) presently has no generic equivalents. Amphastar’s product will be available in boxes containing two single-dose sprays. Its distribution, launch and pricing plans have not been announced.

Impact to Workers’ Comp

Considering the potential of misuse and overdose, opioid antagonists are of interest in those claims where an opioid is prescribed. For any questions about the use of naloxone, opioids, 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
Naloxone Nasal Spray Opioid Antagonist Opioid Overdose Launch pending. Approved March 2023.


Antidepressant Major Depressive Disorder FDA review pending.
Oxycodone (Aximris XR™) Opioid Analgesic – Extended Release Pain FDA review pending.
Buprenorphine Depot Injection (Brixadi™) Opioid Agonist Treatment of
Opioid Addiction
FDA review pending.


NSAID/Serotonin Agonist

Migraine Headache FDA review pending.
Naloxone Nasal Spray (RiVive™) Opioid Antagonist Opioid Overdose FDA review pending for OTC formulation.

Generic Pipeline

Medication (Brand name) Drug Class Therapeutic Use Status Update
Cariprazine (Vraylar®) Antipsychotic Schizophrenia & Bipolar I Disorder Generic approved September 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

Bupropion/Dextromethorphan (Auvelity™

Antidepressant Major Depressive Disorder October 2022
Nalmefene Injection Opioid Antagonist Opioid Overdose June 2022
Baclofen Granules (Lyvispah®) Muscle Relaxant Muscle Spasticity June 2022

Newly Available Generics

Medication (Brand name) Drug Class Therapeutic Use Status Update
Lurasidone (Latuda®) Antidepressant Depression February 2023
Diclofenac Potassium (Cambia®) Solution NSAID Migraine Headache Treatment January 2023
Topiramate (Trokendi XR®) ER Capsule Anticonvulsant Neuropathic Pain January 2023
Dabigatran (Pradaxa®) Anticoagulant Deep Vein Thrombosis June 2022
Vilazodone (Viibryd®) Antidepressant Depression June 2022
Diclofenac Sodium 2% (Pennsaid®) Solution Topical NSAID Pain May 2022

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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