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 |
|---|---|---|---|
|
Ansofaxine |
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. |
|
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. |
| 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. |