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

Loreev XR (lorazepam) extended release capsules

Approval Date: Sep 2021

Note: New Product

For the treatment of anxiety disorders in adults receiving stable, evenly divided, three times daily dosing with lorazepam tablets

Januvia® (sitagliptin) tablets

Approval Date: Sep 2021

Note: New Product

A once-daily medication indicated to help lower blood sugar with type 2 diabetes, in conjunction with diet and exercise

Trudhesa (dihydroergotamine mesylate) nasal spray

Approval Date: Sep 2021

Note: New Product

Indicated for the acute treatment of migraine with or without aura

Qulipta (atogepant) tablets for oral use

Approval Date: Sep 2021

Note: New Product

Indicated for the preventive treatment of episodic migraine

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

Belbuca® (buprenorphine) buccal film

Approval Date: Aug 2021

Note: First-Time Generic

This is the first time a generic has been approved for Belbuca. For the management of pain severe enough to require daily, around the clock, long-term opioid treatment for which alternative treatment options are inadequate

Semglee® (insulin glargine-yfgn) injection for subcutaneous use

Approval Date: Jul 2021

Note: New Product

This is the first time a generic has been approved for Semglee. For the treatment of Type 1 and Type 2 diabetes, this drug is both a biosimilar to, and interchangeable with Lantus (insulin glargine)

WEGOVY (SEMAGLUTIDE) INJECTION

Approval Date: Jun 2021

Note: New Product

For chronic weight management with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol) for use in addition to a reduced calorie diet and increased physical activity

ADUHELM (ADUCANUMAB-AVWA) INJECTION

Approval Date: Jun 2021

Note: New Product

A first-of-its-kind, biologic treatment for Alzheimer’s disease. This drug is the first new Alzheimer’s drug since 2003

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

Kaletra® (lopinavir and ritonavir) tablets

Approval Date: Jun 2021

Note: First-Time Generic

This is the first time a generic has been approved for Kaletra. For the treatment of HIV-1 infection

Intelence® (etravirine) tablets

Approval Date: Jun 2021

Note: First-Time Generic

This is the first time a generic has been approved for Intelence. For the treatment of HIV-1 infection in treatment-experienced patients

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

Loreev XR (lorazepam) extended release capsules

Sep 2021

For the treatment of anxiety disorders in adults receiving stable, evenly divided, three times daily dosing with lorazepam tablets

Note: New Product

Januvia® (sitagliptin) tablets

Sep 2021

A once-daily medication indicated to help lower blood sugar with type 2 diabetes, in conjunction with diet and exercise

Note: New Product

Trudhesa (dihydroergotamine mesylate) nasal spray

Sep 2021

Indicated for the acute treatment of migraine with or without aura

Note: New Product

Qulipta (atogepant) tablets for oral use

Sep 2021

Indicated for the preventive treatment of episodic migraine

Note: New Product

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

Belbuca® (buprenorphine) buccal film

Aug 2021

This is the first time a generic has been approved for Belbuca. For the management of pain severe enough to require daily, around the clock, long-term opioid treatment for which alternative treatment options are inadequate

Note: First-Time Generic

Semglee® (insulin glargine-yfgn) injection for subcutaneous use

Jul 2021

This is the first time a generic has been approved for Semglee. For the treatment of Type 1 and Type 2 diabetes, this drug is both a biosimilar to, and interchangeable with Lantus (insulin glargine)

Note: New Product

WEGOVY (SEMAGLUTIDE) INJECTION

Jun 2021

For chronic weight management with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol) for use in addition to a reduced calorie diet and increased physical activity

Note: New Product

ADUHELM (ADUCANUMAB-AVWA) INJECTION

Jun 2021

A first-of-its-kind, biologic treatment for Alzheimer’s disease. This drug is the first new Alzheimer’s drug since 2003

Note: New Product

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

Kaletra® (lopinavir and ritonavir) tablets

Jun 2021

This is the first time a generic has been approved for Kaletra. For the treatment of HIV-1 infection

Note: First-Time Generic

Intelence® (etravirine) tablets

Jun 2021

This is the first time a generic has been approved for Intelence. For the treatment of HIV-1 infection in treatment-experienced patients

Note: First-Time Generic

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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