Sunlenca® (lenacapavir) tablets
Approval Date: Dec 2022
In combination with other antiretrovirals, this drugs is indicated for treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection
Idacio® (adalimumab-aacf) injection
Approval Date: Dec 2022
Indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis
Tzield® (teplizumab-mzwv) injection
Approval Date: Nov 2022
A first-in-class medication, this drug is indicated to delay the onset of Stage 3 type 1 diabetes, potentially delaying the clinical diagnosis of type 1 diabetes to provide patients with months to years without the burdens of disease.
Daliresp® (roflumilast) tablets
Approval Date: Sep 2022
Indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Tazorac® (tazarotene) gel
Approval Date: Sep 2022
Indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement
Byvalson™ (nebivolol and valsartan) tablets
Approval Date: Sep 2022
Indicated for the treatment of hypertension, to lower blood pressure
Prezista® (darunavir) tablets
Approval Date: Sep 2022
Indicated for the treatment of HIV-1 infection
Sotyktu™ (deucravacitnib) tablets
Approval Date: Sep 2022
Indicated for the treatment of moderate-to-severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy
Jardiance® (empagliflozin) tablets
Approval Date: Aug 2022
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Rexulti® (brexpiprazole) tablets
Approval Date: Aug 2022
Indicated for the adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD)
Banzel® (rufinamide) tablets
Approval Date: Aug 2022
Indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome
Auvelity™ (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets
Approval Date: Aug 2022
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
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
Indicated for the treatment of hypertension to lower blood pressure
Nalfon® (fenoprofen calcium) tablets
Approval Date: 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
Zoryve™ (roflumilast) cream
Approval Date: Jul 2022
Indicated for topical treatment of plaque psoriasis
Zonisade (zonisamide) oral suspension
Approval Date: Jul 2022
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
Indicated for the treatment of partial-onset seizures.
Riabni™ (rituximab-arrx)
Approval Date: 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.
Skyrizi® (risankizumab-rzza) injection
Approval Date: 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.
Vtama® (tapinarof) cream
Approval Date: May 2022
A steroid-free topical indicated for treatment of plaque psoriasis
Olumiant® (baricitinib)
Approval Date: 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
Mounjaro™ (tirzepatide) injection
Approval Date: May 2022
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
Indicated for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder
Vimpat (lacosamide) tablets
Approval Date: Mar 2022
A first-time generic for Vimpat, this drug treats partial onset seizures
Adlarity (donepezil hydrochloride) transdermal system
Approval Date: 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.
Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol
Approval Date: Mar 2022
A first-time generic for Symbicort, this drug is indicated for the treatment of COPD and asthma.
Farxiga (dapgliflozin) tablets
Approval Date: 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.
Revex (nalmefene) injection
Approval Date: 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
Aspruzyo Sprinkle ™ (ranolazine) extended release granules
Approval Date: Feb 2022
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
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
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
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
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
Indicated to reduce the risk of HIV-1 infection
Rezvoglar (insulin glargine-aglr) injection
Approval Date: Dec 2021
Indicated to improve glycemic control for type 1 and 2 diabetes
Yusimry (adalimumab-aqvh) injection
Approval Date: 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
Eprontia™ (topiramate) oral solution
Approval Date: Nov 2021
Indicated for the treatment of seizures, and for the preventive treatment of migraine
Amitiza (lubisprostone) capsules
Approval Date: Nov 2021
Indicated for the treatment of opioid-induced constipation
Zimhi™ (naloxone hydrochloride) injection
Approval Date: Oct 2021
Indicated for the emergency treatment of known or suspected opioid overdose
Seglentis (celecoxib and tramadol hydrochloride) tablets
Approval Date: 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
Cyltezo™ (adlimumab-adbm) injection
Approval Date: 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
Paxil™ (paroxetine) oral suspension
Approval Date: Sep 2021
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
Indicated for the treatment of major depressive disorder (MDD)
Zomig® (zolmitriptan) nasal spray
Approval Date: Sep 2021
Indicated for the acute treatment of migraine with or without aura
Loreev XR (lorazepam) extended release capsules
Approval Date: Sep 2021
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
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
Indicated for the acute treatment of migraine with or without aura
Qulipta™ (atogepant) tablets for oral use
Approval Date: Sep 2021
Indicated for the preventive treatment of episodic migraine
Jentadueto® (linagliptin and metformin hydrochloride) tablets
Approval Date: Aug 2021
Adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes
Tradjenta® (linagliptin) tablets
Approval Date: Aug 2021
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
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
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
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
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
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
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
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
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
This is the first time a generic has been approved for Intelence. For the treatment of HIV-1 infection in treatment-experienced patients
Medication Name
Approval Date
Category
Description
Sunlenca® (lenacapavir) tablets
In combination with other antiretrovirals, this drugs is indicated for treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection
Idacio® (adalimumab-aacf) injection
Indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis
Tzield® (teplizumab-mzwv) injection
A first-in-class medication, this drug is indicated to delay the onset of Stage 3 type 1 diabetes, potentially delaying the clinical diagnosis of type 1 diabetes to provide patients with months to years without the burdens of disease.
Daliresp® (roflumilast) tablets
Indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Tazorac® (tazarotene) gel
Indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement
Byvalson™ (nebivolol and valsartan) tablets
Indicated for the treatment of hypertension, to lower blood pressure
Prezista® (darunavir) tablets
Indicated for the treatment of HIV-1 infection
Sotyktu™ (deucravacitnib) tablets
Indicated for the treatment of moderate-to-severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy
Jardiance® (empagliflozin) tablets
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Rexulti® (brexpiprazole) tablets
Indicated for the adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD)
Banzel® (rufinamide) tablets
Indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome
Auvelity™ (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets
For the treatment of major depressive disorder, this antidepressant is notable for producing antidepressant results within one week
Synjardy® (empagliflozin and metformin hydrochloride) tablets
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Edarbi® (azilsartan medoxomil) tablets
Indicated for the treatment of hypertension to lower blood pressure
Nalfon® (fenoprofen calcium) tablets
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
Indicated for topical treatment of plaque psoriasis
Zonisade (zonisamide) oral suspension
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
Indicated for the treatment of partial-onset seizures.
Riabni™ (rituximab-arrx)
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
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
A steroid-free topical indicated for treatment of plaque psoriasis
Olumiant® (baricitinib)
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
Indicated for the improvement of glycemic control in patients with type 2 diabetes, in conjunction with diet and exercise
Igalmi™ (dexmedetomidine) sublingual film
Indicated for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder
Vimpat (lacosamide) tablets
A first-time generic for Vimpat, this drug treats partial onset seizures
Adlarity (donepezil hydrochloride) transdermal system
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
A first-time generic for Symbicort, this drug is indicated for the treatment of COPD and asthma.
Farxiga (dapgliflozin) tablets
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
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
Indicated for the treatment of chronic angina, a type of chest pain caused by reduced blood flow to the heart.
Norliqva® (amlodipine) oral solution
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
Indicated for the treatment of spasticity resulting from multiple sclerosis, as well as in patients with spinal cord injuries or diseases.
Sovaldi (sofosbuvir) tablets
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
Indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
Apretude (cabotegravir) extended-release injection suspension
Indicated to reduce the risk of HIV-1 infection
Rezvoglar (insulin glargine-aglr) injection
Indicated to improve glycemic control for type 1 and 2 diabetes
Yusimry (adalimumab-aqvh) injection
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
Indicated for the treatment of seizures, and for the preventive treatment of migraine
Amitiza (lubisprostone) capsules
Indicated for the treatment of opioid-induced constipation
Zimhi™ (naloxone hydrochloride) injection
Indicated for the emergency treatment of known or suspected opioid overdose
Seglentis (celecoxib and tramadol hydrochloride) tablets
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
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
Indicated for the treatment of major depressive disorder, obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and PTSD
Trintellix® (vortioxetine) tablets
Indicated for the treatment of major depressive disorder (MDD)
Zomig® (zolmitriptan) nasal spray
Indicated for the acute treatment of migraine with or without aura
Loreev XR (lorazepam) extended release capsules
For the treatment of anxiety disorders in adults receiving stable, evenly divided, three times daily dosing with lorazepam tablets
Januvia® (sitagliptin) tablets
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
Indicated for the acute treatment of migraine with or without aura
Qulipta™ (atogepant) tablets for oral use
Indicated for the preventive treatment of episodic migraine
Jentadueto® (linagliptin and metformin hydrochloride) tablets
Adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes
Tradjenta® (linagliptin) tablets
Adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes
Xeljanz® XR (tofacitnib) extended-release tablets
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
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
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
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
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
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
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
This is the first time a generic has been approved for Kaletra. For the treatment of HIV-1 infection
Intelence® (etravirine) tablets
This is the first time a generic has been approved for Intelence. For the treatment of HIV-1 infection in treatment-experienced patients