January 2023 Report

January 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

Camber Pharmaceuticals has released diclofenac potassium oral solution, a generic for Depomed’s Cambia®. The non-steroidal anti-inflammatory drug (NSAID) is indicated for treating adults who have acute migraines. Diclofenac potassium solution does not prevent migraines and it is not approved to treat cluster headaches. All NSAIDS have boxed warnings that using them may be associated with cardiovascular (CV) events, such as heart attacks or strokes, and that they may increase the possibility of serious gastrointestinal (GI) side effects, such as bleeding and ulcers.

Impact to Workers’ Comp

Migraine agents may be seen in claims following a head injury. Despite the generic availability, other forms of diclofenac may represent more cost-effective alternatives to its use. For any questions about the use of Cambia, NSAIDs, 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


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.

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
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
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

Diclofenac Potassium (Zipsor®) Capsule

NSAID Pain March 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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