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.

FDA Drug Approvals

Med Alerts

Posimir® (bupivacaine solution) for infiltration use

Approval Date: Feb 2021

Note: new product

Indicated for 72-hour post-surgical analgesia following shoulder surgery

Acetaminophen injection

Approval Date: Feb 2021

Note: New Dosage/Formulation

A new 500 mg dose indicated for the management of mild to moderate pain, or moderate to severe pain with adjudicative opioid analgesics

Cabenuva (cabotegravir and rilpivirine extended-release injectable suspension)

Approval Date: Jan 2021

Note: New Product

A complete regimen for the treatment of HIV-1 infection to replace current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure. This is the first FDA-approved injectable, complete regimen for HIV, administered once a month

Norvir® (ritonavir) capsules

Approval Date: Dec 2020

Note: First-Time Generic

Indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection

Veklury® (remdesivir) injection for intravenous use

Approval Date: Oct 2020

Note: new product

Indicated for the treatment of COVID-19 cases requiring hospitalization. Veklury should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care

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

Posimir® (bupivacaine solution) for infiltration use

Feb 2021

Indicated for 72-hour post-surgical analgesia following shoulder surgery

Note: new product

Acetaminophen injection

Feb 2021

A new 500 mg dose indicated for the management of mild to moderate pain, or moderate to severe pain with adjudicative opioid analgesics

Note: New Dosage/Formulation

Cabenuva (cabotegravir and rilpivirine extended-release injectable suspension)

Jan 2021

A complete regimen for the treatment of HIV-1 infection to replace current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure. This is the first FDA-approved injectable, complete regimen for HIV, administered once a month

Note: New Product

Norvir® (ritonavir) capsules

Dec 2020

Indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection

Note: First-Time Generic

Veklury® (remdesivir) injection for intravenous use

Oct 2020

Indicated for the treatment of COVID-19 cases requiring hospitalization. Veklury should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care

Note: new product

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