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MedMonitor

An up-to-date timeline of FDA approvals that could impact workers' comp
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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

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Velsipity (estrasimod) tablets

Approval Date: Oct 2023

Note: New Product

Indicated for the treatment of moderate to severe ulcerative colitis

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Cosentyx® (secukinumab) injection for intravenous use

Approval Date: Oct 2023

Note: New Dosage or Formulation

Indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, ankylosing spondylitis, and other autoimmune conditions, this drug is now available in an intravenous formulation

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Bimzelx® (bimekizumab-bkzx) injection for subcutaneous use

Approval Date: Oct 2023

Note: New Product

Indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

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Combogesic® IV (acetaminophen and ibuprofen)

Approval Date: Oct 2023

Note: Dosage or Formulation

Indicated for the short term management of mild to moderate acute pain, and the management of moderate to severe pain as an adjunct to opioid analgesics, this drug is now available in an intravenous formulation

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Tofidence (tocilizumab-bavi) injection 

Approval Date: Sep 2023

Note: New Product

Indicated for the treatment of rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs)

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Xeljanz (tofacitinib) oral solution

Approval Date: Sep 2023

Note: First-Time Generic

Indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis

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Exxua (gepirone) extended-release tablets

Approval Date: Sep 2023

Note: New Product

Indicated for the treatment of major depressive disorder (MDD), a first-in-class drug that selectively targets the serotonin 1A receptor

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Lexette (halobetasol propionate) topical foam

Approval Date: Aug 2023

Note: First-Time Generic

Indicated for the topical treatment of plaque psoriasis

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Onglyza (saxagliptin) tablets

Approval Date: Jul 2023

Note: First-Time Generic

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

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