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
A generic version of Boehringer Ingelheim’s Pradaxa® (dabigatran oral tablets) is now available, although only for the lower 75 mg strength. Pradaxa is an anticoagulant medication often used for treatment or prophylaxis of various blood clots. It is frequently utilized in certain cardiac conditions or following surgery.
Impact to Workers’ Comp
This is not as impactful as it will be when other anticoagulants become available as generics. The fact that it is only the 75 mg strength will further limit that. For any questions about the use of Pradaxa, anticoagulants, 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 |
|---|---|---|---|
| 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 |
|---|---|---|---|
| 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 |
| 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. |