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MedMonitor

An up-to-date timeline of FDA approvals that could impact workers' comp
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Otulfi™ (ustekinumab-aauz)

Approval Date: Sep 2024

Note: New Product

A biosimilar to Stelara, this drug is indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe Crohn’s disease, and moderate to severe ulcerative colitis

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Zurnai® (nalmefene injection)

Approval Date: Aug 2024

Note: New Product

An opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids.

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Neffy® (epinephrine nasal spray)

Approval Date: Aug 2024

Note: New Product

Indicated for the emergency treatment of type I allergic reactions, including anaphylaxis

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Tezruly™ (terazosin) oral solution

Approval Date: Jul 2024

Note: New Product

Indicated for the treatment of hypertension alone or with other antihypertensive agents, and for the treatment of enlarged prostate

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Zunveyl (benzgalantamine) delayed-release tablets

Approval Date: Jul 2024

Note: New Product

Indicated for the treatment of mild to moderate dementia of the Alzheimer's type

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Olumiant (baricitinib) tablets

Approval Date: Jul 2024

Note: First-Time Generic

Indicated for the treatment of moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers

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Kisunla (donanemab-azbt) injection

Approval Date: Jul 2024

Note: New Product

Indicated for the treatment of Alzheimer's disease. Treatment with Kisunla should be initiated in patient with mild cognitive impairment or mild dementia stage of disease, the population in which the treatment was initiated in the clinical trials

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Qsymia® (phentermine and topiramate) extended-release tablets

Approval Date: Jun 2024

Note: First-Time Generic

Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management

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Stendra® (avanafil) tablets

Approval Date: Jun 2024

Note: First-Time Generic

Indicated for the treatment of erectile dysfunction

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Pyzchiva® (Ustekinumab-ttwe) injection

Approval Date: Jun 2024

Note: Biosimilar

A biosimilar to Stelara; indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis

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