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
Perforomist® (formoterol fumarate) inhalation solution
Approval Date: 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
Brovana® (arformoterol tartrate) inhalation solution
Approval Date: 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
Aptiom® (eslicarbazepine acetate) tablets
Approval Date: Jun 2021
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
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
A combination antipsychotic and opioid antagonist for the treatment of schizophrenia, bipolar I disorder
KLOXXADO™ (NALOXONE HYDROCHLORIDE) NASAL SPRAY
Approval Date: 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
LYRICA® CR (PREGABALIN) EXTENDED-RELEASE TABLETS
Approval Date: 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
HYSINGLA® ER (HYDROCODONE BITARTRATE) EXTENDED-RELEASE TABLETS
Approval Date: 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
ZEGALOGUE® (DASIGLUCAGON) INJECTION FOR SUBCUTANEOUS USE
Approval Date: Mar 2021
For the treatment of severe hypoglycemia in diabetic patients
Posimir® (bupivacaine solution) for infiltration use
Approval Date: Feb 2021
Indicated for 72-hour post-surgical analgesia following shoulder surgery
Acetaminophen injection
Approval Date: 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
Cabenuva (cabotegravir and rilpivirine extended-release injectable suspension)
Approval Date: 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
Norvir® (ritonavir) capsules
Approval Date: Dec 2020
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
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
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
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
Perforomist® (formoterol fumarate) inhalation solution
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
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
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
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
A combination antipsychotic and opioid antagonist for the treatment of schizophrenia, bipolar I disorder
KLOXXADO™ (NALOXONE HYDROCHLORIDE) NASAL SPRAY
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
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
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
For the treatment of severe hypoglycemia in diabetic patients
Posimir® (bupivacaine solution) for infiltration use
Indicated for 72-hour post-surgical analgesia following shoulder surgery
Acetaminophen injection
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)
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
Indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection
Veklury® (remdesivir) injection for intravenous use
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
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