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MedMonitor

An up-to-date timeline of FDA approvals that could impact workers' comp
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Opvee® (nalmefene hydrochloride) nasal spray

Approval Date: May 2023

Note: New Product

Indicated for the emergency treatment of known or suspected opioid overdose. This is the first approval of nalmefene hydrochloride nasal spray for health care and community use

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Brixadi (buprenorphine) extended-release injection

Approval Date: May 2023

Note: New Product

Indicated for the treatment of moderate to severe opioid use disorder (OUD). Brixadi is administered in a healthcare setting and is available in weekly or monthly formulations, each at various dosages

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Motpoly XR (lacosamide)

Approval Date: May 2023

Note: New Product

Indicated for the treatment of partial-onset seizures in adults

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Abilify Asimtufii® (aripiprazole)

Approval Date: Apr 2023

Note: New Formulation

Indicated for the treatment of schizophrenia or as maintenance monotherapy treatment of bipolar I disorder

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Uzedy (risperidone) extended-release injectable suspension

Approval Date: Apr 2023

Note: New Formulation

Indicated for the treatment of schizophrenia in adults

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Zavzpret (zavegepant) nasal spray

Approval Date: Mar 2023

Note: New Product

Indicated for the acute treatment of migraine with or without aura

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Combogesic® (acetaminophen and ibuprofen) tablets

Approval Date: Mar 2023

Note: New Product

Indicated for the short term management of mild to moderate acute pain

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Trokendi XR (topiramate) extended-release capsules

Approval Date: Feb 2023

Note: First-Time Generic

Indicated for the treatment of partial-onset or primary generalized tonic-clonic seizures, adjunctive therapy for partial-onset, primary generalized tonic-clonic seizures, seizures associated with Lennox-Gastaut syndrome (LGS), and preventive treatment of migraine

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Advil Dual Action (acetaminophen and ibuprofen) tablets (OTC)

Approval Date: Feb 2023

Note: First-Time Generic

Temporarily relieves minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis

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Leqembi (lecnemab-irmb) injection

Approval Date: Jan 2023

Note: New Product

Indicated for the treatment of Alzheimer’s in patients with mild cognitive impairment or mild dementia sage of the disease

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Sunlenca® (lenacapavir) tablets

Approval Date: Dec 2022

Note: New Product

In combination with other antiretrovirals, this drugs is indicated for treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection

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Idacio® (adalimumab-aacf) injection

Approval Date: Dec 2022

Note: New Product

Indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis

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Tzield® (teplizumab-mzwv) injection

Approval Date: Nov 2022

Note: New Product

A first-in-class medication, this drug is indicated to delay the onset of Stage 3 type 1 diabetes, potentially delaying the clinical diagnosis of type 1 diabetes to provide patients with months to years without the burdens of disease.

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Daliresp® (roflumilast) tablets

Approval Date: Sep 2022

Note: First-Time Generic

Indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations

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Tazorac® (tazarotene) gel

Approval Date: Sep 2022

Note: First-Time Generic

Indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement

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