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. |
|
Meloxicam/Rizatriptan |
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. |