September 2022 Report

September 2022 Report

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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

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 ClassTherapeutic UseStatus Update
Bupropion/Dextromethorphan (Auvelity™)AntidepressantMajor Depressive DisorderLaunch pending. Approved August 18, 2022.
Buprenorphine Depot Injection (Brixadi™)Opioid AgonistTreatment of
Opioid Addiction
FDA review pending.
Oxycodone (Aximris XR™)Opioid Analgesic –
Extended Release
PainFDA review pending.
Meloxicam/RizatriptanNSAID/Serotonin AgonistMigraine HeadacheFDA review pending.

Generic Pipeline

Medication (Brand name)Drug ClassTherapeutic UseStatus Update
Cariprazine (Vraylar®)AntipsychoticSchizophrenia & Bipolar I DisorderGeneric approved September 2022.
Oxycodone HCl (Oxaydo®)Opioid AgonistPainGeneric exclusivity anticipated in 2022.
Apixaban (Eliquis®)AnticoagulantTreatment/Prophylaxis of Deep Vein ThrombosisGenerics 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 ClassTherapeutic UseStatus Update
Nalmefene InjectionOpioid AntagonistOpioid OverdoseJune 2022
Baclofen Granules (Lyvispah®)Muscle RelaxantMuscle SpasticityJune 2022
Naloxone Injection (Zimhi™)Opioid AntagonistOpioid OverdoseMarch 2022
Celecoxib/Tramadol (Seglentis®)NSAID/Opioid AgonistPainMarch 2022
Baclofen Oral Suspension (Fleqsuvy™)Muscle RelaxantMuscle SpasmsMarch 2022
Celecoxib Oral Liquid (Elyxyb™)NSAIDMigraine Headache TreatmentFebruary 2022

Newly Available Generics

Medication (Brand name)Drug ClassTherapeutic UseStatus Update
Dabigatran (Pradaxa®)AnticoagulantDeep Vein ThrombosisJune 2022
Vilazodone (Viibryd®)AntidepressantDepressionJune 2022
Diclofenac Sodium 2% (Pennsaid®) SolutionTopical NSAIDPainMay 2022
Diclofenac Potassium (Zipsor®) CapsuleNSAIDPainMarch 2022
Naloxone HCl (Narcan®) Nasal SprayOpioid AntagonistOpioid OverdoseDecember 2021
Zolmitriptan Nasal Spray (Zomig®)Serotonin AgonistMigraine Headache TreatmentNovember 2021

Discontinuations & Withdrawals

Medication (Brand name)Drug ClassTherapeutic UseStatus Update
Hydrocodone ER Capsules (Zohydro® ER)Opioid AgonistPainManufacturer has stopped distribution and FDA has rescinded approval effective February 2022.

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