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

Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets

Approval Date: Aug 2022

Note: New Product

For the treatment of major depressive disorder, this antidepressant is notable for producing antidepressant results within one week

Synjardy® (empagliflozin and metformin hydrochloride) tablets

Approval Date: Jul 2022

Note: First-Time Generic

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

Edarbi® (azilsartan medoxomil) tablets

Approval Date: Jul 2022

Note: First-Time Generic

Indicated for the treatment of hypertension to lower blood pressure

Nalfon® (fenoprofen calcium) tablets

Approval Date: Jul 2022

Note: First-Time Generic

An NSAID used for the relief of mild to moderate pain or relief in the signs and symptoms of rheumatoid arthritis or osteoarthritis

Zoryve (roflumilast) cream

Approval Date: Jul 2022

Note: New Product

Indicated for topical treatment of plaque psoriasis

Zonisade (zonisamide) oral suspension

Approval Date: Jul 2022

Note: New Dosage or Formulation

Indicated as an adjunctive therapy for the treatment of partial-onset seizures, this approval is for the first liquid formulation of zonisamide.

Briviact (brivaracetam) tablets

Approval Date: Jun 2022

Note: First-Time Generic

Indicated for the treatment of partial-onset seizures.

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.

Vtama® (tapinarof) cream

Approval Date: May 2022

Note: New Product

A steroid-free topical indicated for treatment of plaque psoriasis

Olumiant® (baricitinib)

Approval Date: May 2022

Note: New Product

Indicated for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, and other assistance with breathing

Mounjaro (tirzepatide) injection

Approval Date: May 2022

Note: New Product

Indicated for the improvement of glycemic control in patients with type 2 diabetes, in conjunction with diet and exercise

Igalmi (dexmedetomidine) sublingual film

Approval Date: Apr 2022

Note: New Product

Indicated for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder

Vimpat (lacosamide) tablets

Approval Date: Mar 2022

Note: First-Time Generic

A first-time generic for Vimpat, this drug treats partial onset seizures

Adlarity (donepezil hydrochloride) transdermal system

Approval Date: Mar 2022

Note: New Product

Indicated for the treatment of mild-to-severe dementia of the Alzheimer’s type. This product is the first transdermal patch for this indication.

Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol

Approval Date: Mar 2022

Note: First-Time Generic

A first-time generic for Symbicort, this drug is indicated for the treatment of COPD and asthma.

Farxiga (dapgliflozin) tablets

Approval Date: Feb 2022

Note: First-Time Generic

A first-time generic for Farxiga, a medication used to treat type 2 diabetes, as well as adults with certain kinds of heart failure chronic kidney disease.

Revex (nalmefene) injection

Approval Date: Feb 2022

Note: First-Time Generic

A first-time generic of Revex, this drug is indicated for the complete or partial reversal of opioid drug effects, including respiratory depressions from natural or synthetic opioids, and for the management of opioid overdose

Aspruzyo Sprinkle (ranolazine) extended release granules

Approval Date: Feb 2022

Note: New Product

Indicated for the treatment of chronic angina, a type of chest pain caused by reduced blood flow to the heart.

Norliqva® (amlodipine) oral solution

Approval Date: Feb 2022

Note: New Product

A peppermint-flavored solution indicated for the treatment of hypertension and angina. Amlodipine is available as a generic in oral tablets.

Fleqsuvy (baclofen) oral suspension

Approval Date: Feb 2022

Note: New Product

Indicated for the treatment of spasticity resulting from multiple sclerosis, as well as in patients with spinal cord injuries or diseases.

Sovaldi (sofosbuvir) tablets

Approval Date: Jan 2022

Note: First-Time Generic

Indicated for the treatment of Hepatitis C genotypes 1-4 in patients without cirrhosis, or with compensated cirrhosis as part of a combination antiviral treatment regimen.

Quviviq (daridorexant) tablets

Approval Date: Jan 2022

Note: New Product

Indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Apretude (cabotegravir) extended-release injection suspension

Approval Date: Dec 2021

Note: New Product

Indicated to reduce the risk of HIV-1 infection

Rezvoglar (insulin glargine-aglr) injection

Approval Date: Dec 2021

Note: New Product, Biosimilar

Indicated to improve glycemic control for type 1 and 2 diabetes

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

Eprontia (topiramate) oral solution

Approval Date: Nov 2021

Note: New Product

Indicated for the treatment of seizures, and for the preventive treatment of migraine

Amitiza (lubisprostone) capsules

Approval Date: Nov 2021

Note: First-Time Generic

Indicated for the treatment of opioid-induced constipation

Zimhi (naloxone hydrochloride) injection

Approval Date: Oct 2021

Note: New Product

Indicated for the emergency treatment of known or suspected opioid overdose

Seglentis (celecoxib and tramadol hydrochloride) tablets

Approval Date: Oct 2021

Note: New Product

A combination opioid agonist and NSAID indicated for the management of acute pain severe enough to require an opioid and for which alternative treatments are inadequate

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

Paxil (paroxetine) oral suspension

Approval Date: Sep 2021

Note: First-Time Generic

Indicated for the treatment of major depressive disorder, obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and PTSD

Trintellix® (vortioxetine) tablets

Approval Date: Sep 2021

Note: First-Time Generic

Indicated for the treatment of major depressive disorder (MDD)

Zomig® (zolmitriptan) nasal spray

Approval Date: Sep 2021

Note: First-Time Generic

Indicated for the acute treatment of migraine with or without aura

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

Jentadueto® (linagliptin and metformin hydrochloride) tablets

Approval Date: Aug 2021

Note: First-Time Generic

Adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes

Tradjenta® (linagliptin) tablets

Approval Date: Aug 2021

Note: First-Time Generic

Adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes

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

Medication Name

Approval Date

Category

Description

Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets

Aug 2022

For the treatment of major depressive disorder, this antidepressant is notable for producing antidepressant results within one week

Note: New Product

Synjardy® (empagliflozin and metformin hydrochloride) tablets

Jul 2022

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

Note: First-Time Generic

Edarbi® (azilsartan medoxomil) tablets

Jul 2022

Indicated for the treatment of hypertension to lower blood pressure

Note: First-Time Generic

Nalfon® (fenoprofen calcium) tablets

Jul 2022

An NSAID used for the relief of mild to moderate pain or relief in the signs and symptoms of rheumatoid arthritis or osteoarthritis

Note: First-Time Generic

Zoryve (roflumilast) cream

Jul 2022

Indicated for topical treatment of plaque psoriasis

Note: New Product

Zonisade (zonisamide) oral suspension

Jul 2022

Indicated as an adjunctive therapy for the treatment of partial-onset seizures, this approval is for the first liquid formulation of zonisamide.

Note: New Dosage or Formulation

Briviact (brivaracetam) tablets

Jun 2022

Indicated for the treatment of partial-onset seizures.

Note: First-Time Generic

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

Vtama® (tapinarof) cream

May 2022

A steroid-free topical indicated for treatment of plaque psoriasis

Note: New Product

Olumiant® (baricitinib)

May 2022

Indicated for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, and other assistance with breathing

Note: New Product

Mounjaro (tirzepatide) injection

May 2022

Indicated for the improvement of glycemic control in patients with type 2 diabetes, in conjunction with diet and exercise

Note: New Product

Igalmi (dexmedetomidine) sublingual film

Apr 2022

Indicated for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder

Note: New Product

Vimpat (lacosamide) tablets

Mar 2022

A first-time generic for Vimpat, this drug treats partial onset seizures

Note: First-Time Generic

Adlarity (donepezil hydrochloride) transdermal system

Mar 2022

Indicated for the treatment of mild-to-severe dementia of the Alzheimer’s type. This product is the first transdermal patch for this indication.

Note: New Product

Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol

Mar 2022

A first-time generic for Symbicort, this drug is indicated for the treatment of COPD and asthma.

Note: First-Time Generic

Farxiga (dapgliflozin) tablets

Feb 2022

A first-time generic for Farxiga, a medication used to treat type 2 diabetes, as well as adults with certain kinds of heart failure chronic kidney disease.

Note: First-Time Generic

Revex (nalmefene) injection

Feb 2022

A first-time generic of Revex, this drug is indicated for the complete or partial reversal of opioid drug effects, including respiratory depressions from natural or synthetic opioids, and for the management of opioid overdose

Note: First-Time Generic

Aspruzyo Sprinkle (ranolazine) extended release granules

Feb 2022

Indicated for the treatment of chronic angina, a type of chest pain caused by reduced blood flow to the heart.

Note: New Product

Norliqva® (amlodipine) oral solution

Feb 2022

A peppermint-flavored solution indicated for the treatment of hypertension and angina. Amlodipine is available as a generic in oral tablets.

Note: New Product

Fleqsuvy (baclofen) oral suspension

Feb 2022

Indicated for the treatment of spasticity resulting from multiple sclerosis, as well as in patients with spinal cord injuries or diseases.

Note: New Product

Sovaldi (sofosbuvir) tablets

Jan 2022

Indicated for the treatment of Hepatitis C genotypes 1-4 in patients without cirrhosis, or with compensated cirrhosis as part of a combination antiviral treatment regimen.

Note: First-Time Generic

Quviviq (daridorexant) tablets

Jan 2022

Indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Note: New Product

Apretude (cabotegravir) extended-release injection suspension

Dec 2021

Indicated to reduce the risk of HIV-1 infection

Note: New Product

Rezvoglar (insulin glargine-aglr) injection

Dec 2021

Indicated to improve glycemic control for type 1 and 2 diabetes

Note: New Product, Biosimilar

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

Eprontia (topiramate) oral solution

Nov 2021

Indicated for the treatment of seizures, and for the preventive treatment of migraine

Note: New Product

Amitiza (lubisprostone) capsules

Nov 2021

Indicated for the treatment of opioid-induced constipation

Note: First-Time Generic

Zimhi (naloxone hydrochloride) injection

Oct 2021

Indicated for the emergency treatment of known or suspected opioid overdose

Note: New Product

Seglentis (celecoxib and tramadol hydrochloride) tablets

Oct 2021

A combination opioid agonist and NSAID indicated for the management of acute pain severe enough to require an opioid and for which alternative treatments are inadequate

Note: New Product

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

Paxil (paroxetine) oral suspension

Sep 2021

Indicated for the treatment of major depressive disorder, obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and PTSD

Note: First-Time Generic

Trintellix® (vortioxetine) tablets

Sep 2021

Indicated for the treatment of major depressive disorder (MDD)

Note: First-Time Generic

Zomig® (zolmitriptan) nasal spray

Sep 2021

Indicated for the acute treatment of migraine with or without aura

Note: First-Time Generic

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

Jentadueto® (linagliptin and metformin hydrochloride) tablets

Aug 2021

Adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes

Note: First-Time Generic

Tradjenta® (linagliptin) tablets

Aug 2021

Adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes

Note: First-Time Generic

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
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