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

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

Duexis® (ibuprofen and famotidine) tablets

Approval Date: Aug 2021

Note: First-Time Generic

This is the first time a generic has been approved for Duexis. For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis, and to decrease the risk of developing upper gastrointestinal ulcers

Xeljanz® (tofacitnib) tablets

Approval Date: Jun 2021

Note: First-Time Generic

This is the first time a generic has been approved for Xeljanz. For the treatment of moderate-to-severe active rheumatoid arthritis, and psoriatic arthritis

Xeljanz® (tofacitinib) oral solution

Approval Date: Sep 2020

Note: new dosage or formulation

A new oral solution formulation, this drug is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis

Medication Name

Approval Date

Category

Description

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

Duexis® (ibuprofen and famotidine) tablets

Aug 2021

This is the first time a generic has been approved for Duexis. For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis, and to decrease the risk of developing upper gastrointestinal ulcers

Note: First-Time Generic

Xeljanz® (tofacitnib) tablets

Jun 2021

This is the first time a generic has been approved for Xeljanz. For the treatment of moderate-to-severe active rheumatoid arthritis, and psoriatic arthritis

Note: First-Time Generic

Xeljanz® (tofacitinib) oral solution

Sep 2020

A new oral solution formulation, this drug is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis

Note: new dosage or formulation
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