Medmonitor

An up-to-date timeline of U.S. Food and Drug Administration (FDA) approvals that could potentially impact workers' compensation. These include new drug and indication approvals, new dosages or formulations of existing products, and generics introduced to the market. Click through the interactive timeline below, or select the comprehensive list view.
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Medication Type: Autoimmune

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

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

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

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

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

Lexette (halobetasol propionate) topical foam

Approval Date: Aug 2023

Note: First-Time Generic

Indicated for the topical treatment of plaque psoriasis

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)

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

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

Yuflyma (adalimumab-aaty) injection

Approval Date: May 2023

Note: New Product

A biosimilar to Humira (adalimumab) this drug is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s Disease, ulcerative colitis, and plaque psoriasis

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Medication Name

Approval Date

Category

Description

Simlandi® (adalimumab-ryvk) injection

Feb 2024

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

Note: Biosimilar

Xeljanz (tofacitinib) oral solution

Sep 2023

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

Note: First-Time Generic

Zymfentra (infliximab-dyyb) injection

Oct 2023

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

Note: New Product

Omvoh (mirikizumab-mrkz) injection

Oct 2023

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

Note: New Product

Wezlana (ustekinumab-auub) injection

Oct 2023

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

Note: Biosimilar

Lexette (halobetasol propionate) topical foam

Aug 2023

Indicated for the topical treatment of plaque psoriasis

Note: First-Time Generic

Tofidence (tocilizumab-bavi) injection 

Sep 2023

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)

Note: New Product

Cosentyx® (secukinumab) injection for intravenous use

Oct 2023

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

Note: New Dosage or Formulation

Bimzelx® (bimekizumab-bkzx) injection for subcutaneous use

Oct 2023

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

Note: New Product

Yuflyma (adalimumab-aaty) injection

May 2023

A biosimilar to Humira (adalimumab) this drug is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s Disease, ulcerative colitis, and plaque psoriasis

Note: New Product
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