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

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

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

Sotyktu (deucravacitnib) tablets

Approval Date: Sep 2022

Note: New Product

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

Zoryve (roflumilast) cream

Approval Date: Jul 2022

Note: New Product

Indicated for topical treatment of plaque psoriasis

Vtama® (tapinarof) cream

Approval Date: May 2022

Note: New Product

A steroid-free topical indicated for treatment of plaque psoriasis

Riabni (rituximab-arrx)

Approval Date: Jun 2022

Note: New Indication

A biosimilar to Rituxan® with existing oncology indications, this drug is now approved for the treatment of moderate-to-severe rheumatoid arthritis, in combination with methotrexate.

Skyrizi® (risankizumab-rzza) injection

Approval Date: Jun 2022

Note: New Indication

Approved for its third indication for moderately to severely active Crohn’s disease, in addition to existing indications for moderate-to-severe plaque psoriasis and active psoriatic arthritis.

Yusimry (adalimumab-aqvh) injection

Approval Date: Dec 2021

Note: New Product, Biosimilar

The 7th biosimilar approved for adalimumab. For the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s Disease, ulcerative colitis, and plaque psoriasis

Cyltezo (adlimumab-adbm) injection

Approval Date: Oct 2021

Note: Biosimilar

A biosimilar to Humira, this drug is now officially interchangeable with Humira for the treatment  of moderate-to-severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe Crohn’s disease, moderate-to-severe ulcerative colitis, and moderate-to-severe chronic plaque psoriasis

Xeljanz® XR (tofacitnib) extended-release tablets

Approval Date: Aug 2021

Note: First-Time Generic

This is the first time a generic has been approved for Xeljanz XR – other formulations of Xeljanz have received generic approvals, but this new generic approval applies to the extended-release formulation. For the treatment of moderate-to-severe active rheumatoid arthritis, active psoriatic arthritis, or ulcerative colitis

Medication Name

Approval Date

Category

Description

Idacio® (adalimumab-aacf) injection

Dec 2022

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

Note: New Product

Tazorac® (tazarotene) gel

Sep 2022

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

Note: First-Time Generic

Sotyktu (deucravacitnib) tablets

Sep 2022

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

Note: New Product

Zoryve (roflumilast) cream

Jul 2022

Indicated for topical treatment of plaque psoriasis

Note: New Product

Vtama® (tapinarof) cream

May 2022

A steroid-free topical indicated for treatment of plaque psoriasis

Note: New Product

Riabni (rituximab-arrx)

Jun 2022

A biosimilar to Rituxan® with existing oncology indications, this drug is now approved for the treatment of moderate-to-severe rheumatoid arthritis, in combination with methotrexate.

Note: New Indication

Skyrizi® (risankizumab-rzza) injection

Jun 2022

Approved for its third indication for moderately to severely active Crohn’s disease, in addition to existing indications for moderate-to-severe plaque psoriasis and active psoriatic arthritis.

Note: New Indication

Yusimry (adalimumab-aqvh) injection

Dec 2021

The 7th biosimilar approved for adalimumab. For the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s Disease, ulcerative colitis, and plaque psoriasis

Note: New Product, Biosimilar

Cyltezo (adlimumab-adbm) injection

Oct 2021

A biosimilar to Humira, this drug is now officially interchangeable with Humira for the treatment  of moderate-to-severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe Crohn’s disease, moderate-to-severe ulcerative colitis, and moderate-to-severe chronic plaque psoriasis

Note: Biosimilar

Xeljanz® XR (tofacitnib) extended-release tablets

Aug 2021

This is the first time a generic has been approved for Xeljanz XR – other formulations of Xeljanz have received generic approvals, but this new generic approval applies to the extended-release formulation. For the treatment of moderate-to-severe active rheumatoid arthritis, active psoriatic arthritis, or ulcerative colitis

Note: First-Time Generic
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