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MedMonitor

An up-to-date timeline of FDA approvals that could impact workers' comp
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Selarsdi (Ustekinumab-aekn) injection

Approval Date: Apr 2024

Note: Biosimilar, New Product

A biosimilar of Stelara®, this drug is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis

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Risvan® (risperidone) for extended-release injectable suspension

Approval Date: Mar 2024

Note: New Product

A long-acting, atypical antipsychotic indicated for the treatment of schizophrenia

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Winrevair (sotatercept-csrk) injections

Approval Date: Mar 2024

Note: Biologic, New Product

A first-in-class biologic indicated for the treatment of pulmonary arterial hypertension to increase exercise capacity and reduce the risk of clinical worsening events

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Opsynvi® (macitentan and tadalafil) tablets

Approval Date: Mar 2024

Note: New Product

Indicated for the treatment of pulmonary arterial hypertension, both in patients who are treatment naïve or who are already on an ERA, PDE5 inhibitor or both

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Tryvio (aprocitentan) tablets

Approval Date: Mar 2024

Note: New Product

Indicated for the treatment of hypertension in combination with other antihypertensive drugs to lower blood pressure

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Simlandi® (adalimumab-ryvk) injection

Approval Date: Feb 2024

Note: Biosimilar

A biosimilar to Humira, this drug is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, and plaque psoriasis

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Tybost (cobicistat) tablets

Approval Date: Feb 2024

Note: First-Time Generic

Indicated for the treatment of HIV-1 infection

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Dilaudid (hydromorphone hydrochloride) injection

Approval Date: Feb 2024

Note: First-Time Generic

Indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate

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Namzaric® (memantine and donepezil hydrochloride) extended release capsules

Approval Date: Dec 2023

Note: First-Time Generic

Indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily

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Zepbound (tirzepatide) injection

Approval Date: Nov 2023

Note: New Product

Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in obese adults, or overweight adults with at least one weight-related comorbidity

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Zituvimet (sitagliptin and metformin hydrochloride) tablets

Approval Date: Nov 2023

Note: New Product

Indicated as an adjunct to diet and exercise to improve glycemic control of type 2 diabetes

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Voquezna (vonoprazan fumarate) tablets

Approval Date: Nov 2023

Note: New Product

Indicated for erosive esophagitis and the relief of heartburn associated with erosive esophagitis

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Zymfentra (infliximab-dyyb) injection

Approval Date: Oct 2023

Note: New Product

Indicated for the maintenance treatment of moderate to severe ulcerative colitis or moderate to severe Crohn’s disease, following treatment with an infliximab product administered intravenously

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Omvoh (mirikizumab-mrkz) injection

Approval Date: Oct 2023

Note: New Product

A first-in-class agent indicated for the treatment of moderate to severe ulcerative colitis

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Wezlana (ustekinumab-auub) injection

Approval Date: Oct 2023

Note: Biosimilar

A biosimilar to Stelara, indicated for the treatment of moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severe Crohn’s disease, and moderate to severe ulcerative colitis

hello world!

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