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

Perforomist® (formoterol fumarate) inhalation solution

Approval Date: Jun 2021

Note: First-Time Generic

This is the first time a generic has been approved for Perforomist. For the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

Brovana® (arformoterol tartrate) inhalation solution

Approval Date: Jun 2021

Note: First-Time Generic

This is the first time a generic has been approved for Brovana. For the long-term, twice daily administration in the maintenance of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

Aptiom® (eslicarbazepine acetate) tablets

Approval Date: Jun 2021

Note: First-Time Generic

This is the first time a generic has been approved for Aptiom. For the adjunctive treatment of partial-onset seizures

ZYNRELEF (BUPIVACAINE AND MELOXICAM) EXTENDED-RELEASE SOLUTION

Approval Date: May 2021

Note: New Product

A combination of an amide local anesthetic and an NSAID for postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty

LYBALVI (OLANZAPINE AND SAMIDORPHAN) TABLETS FOR ORAL USE

Approval Date: May 2021

Note: New Product

A combination antipsychotic and opioid antagonist for the treatment of schizophrenia, bipolar I disorder

KLOXXADO (NALOXONE HYDROCHLORIDE) NASAL SPRAY

Approval Date: Apr 2021

Note: New Product

For the emergency treatment of known or suspected opioid overdose. While other naloxone sprays were previously available in 2 mg and 4 mg doses, this drug has been approved at an 8 mg dose

LYRICA® CR (PREGABALIN) EXTENDED-RELEASE TABLETS

Approval Date: Apr 2021

Note: First-Time Generic

For the management of neuropathic pain associated with diabetic neuropathy; post-herpetic neuralgia. While previous generic versions of Lyrica have been approved in the past, this generic approval is for the Extended-Release tablets

HYSINGLA® ER (HYDROCODONE BITARTRATE) EXTENDED-RELEASE TABLETS

Approval Date: Mar 2021

Note: First-Time Generic

For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

ZEGALOGUE® (DASIGLUCAGON) INJECTION FOR SUBCUTANEOUS USE

Approval Date: Mar 2021

Note: New Product

For the treatment of severe hypoglycemia in diabetic patients

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

Perforomist® (formoterol fumarate) inhalation solution

Jun 2021

This is the first time a generic has been approved for Perforomist. For the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

Note: First-Time Generic

Brovana® (arformoterol tartrate) inhalation solution

Jun 2021

This is the first time a generic has been approved for Brovana. For the long-term, twice daily administration in the maintenance of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

Note: First-Time Generic

Aptiom® (eslicarbazepine acetate) tablets

Jun 2021

This is the first time a generic has been approved for Aptiom. For the adjunctive treatment of partial-onset seizures

Note: First-Time Generic

ZYNRELEF (BUPIVACAINE AND MELOXICAM) EXTENDED-RELEASE SOLUTION

May 2021

A combination of an amide local anesthetic and an NSAID for postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty

Note: New Product

LYBALVI (OLANZAPINE AND SAMIDORPHAN) TABLETS FOR ORAL USE

May 2021

A combination antipsychotic and opioid antagonist for the treatment of schizophrenia, bipolar I disorder

Note: New Product

KLOXXADO (NALOXONE HYDROCHLORIDE) NASAL SPRAY

Apr 2021

For the emergency treatment of known or suspected opioid overdose. While other naloxone sprays were previously available in 2 mg and 4 mg doses, this drug has been approved at an 8 mg dose

Note: New Product

LYRICA® CR (PREGABALIN) EXTENDED-RELEASE TABLETS

Apr 2021

For the management of neuropathic pain associated with diabetic neuropathy; post-herpetic neuralgia. While previous generic versions of Lyrica have been approved in the past, this generic approval is for the Extended-Release tablets

Note: First-Time Generic

HYSINGLA® ER (HYDROCODONE BITARTRATE) EXTENDED-RELEASE TABLETS

Mar 2021

For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

Note: First-Time Generic

ZEGALOGUE® (DASIGLUCAGON) INJECTION FOR SUBCUTANEOUS USE

Mar 2021

For the treatment of severe hypoglycemia in diabetic patients

Note: New Product

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
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