Velsipity™ (estrasimod) tablets
Approval Date: Oct 2023
Indicated for the treatment of moderate to severe ulcerative colitis
Cosentyx® (secukinumab) injection for intravenous use
Approval Date: Oct 2023
Indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, ankylosing spondylitis, and other autoimmune conditions, this drug is now available in an intravenous formulation
Bimzelx® (bimekizumab-bkzx) injection for subcutaneous use
Approval Date: Oct 2023
Indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
Combogesic® IV (acetaminophen and ibuprofen)
Approval Date: Oct 2023
Indicated for the short term management of mild to moderate acute pain, and the management of moderate to severe pain as an adjunct to opioid analgesics, this drug is now available in an intravenous formulation
Tofidence™ (tocilizumab-bavi) injection
Approval Date: Sep 2023
Indicated for the treatment of rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs)
Exxua™ (gepirone) extended-release tablets
Approval Date: Sep 2023
Indicated for the treatment of major depressive disorder (MDD), a first-in-class drug that selectively targets the serotonin 1A receptor
Lexette (halobetasol propionate) topical foam
Approval Date: Aug 2023
Indicated for the topical treatment of plaque psoriasis
Onglyza™ (saxagliptin) tablets
Approval Date: Jul 2023
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Kombiglyze® XR (saxagliptin and metformin hydrochloride) extended-release tablets
Approval Date: Jul 2023
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate
RiVive™ (naloxone hydrochloride) nasal spray
Approval Date: Jul 2023
Indicated for the emergency treatment of known or suspected opioid overdose, this drug is the second over-the-counter nonprescription opioid overdose drug approved by the FDA
Spiriva® HandiHaler (tiotropium bromide) inhalation powder
Approval Date: Jun 2023
For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Katerzia® (amlodipine benzoate) oral suspension
Approval Date: Jun 2023
For the treatment of hypertension and coronary artery disease
Fleqsuvy™ (baclofen) oral suspension
Approval Date: Jun 2023
Indicated for the treatment of spasticity resulting from multiple sclerosis, as well as in patients with spinal cord injuries or diseases.
Diastat® AcuDial (diazepam) rectal gel delivery system
Approval Date: May 2023
Indicated for the management of selected, refractory, patients with epilepsy, on stable regimens of anti-epileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity
Celontin® (methsuximide) capsules
Approval Date: May 2023
Indicated for the control of absence (petit mal) seizures that are refractory to other drugs
Yuflyma™ (adalimumab-aaty) injection
Approval Date: May 2023
A biosimilar to Humira (adalimumab) this drug is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s Disease, ulcerative colitis, and plaque psoriasis
Paxlovid™ (nirmatrelvir and ritonavir) tablets
Approval Date: May 2023
Indicated for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19
Inpefa™ (sotagliflozin) tablets
Approval Date: May 2023
Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes
Opvee® (nalmefene hydrochloride) nasal spray
Approval Date: May 2023
Indicated for the emergency treatment of known or suspected opioid overdose. This is the first approval of nalmefene hydrochloride nasal spray for health care and community use
Brixadi™ (buprenorphine) extended-release injection
Approval Date: May 2023
Indicated for the treatment of moderate to severe opioid use disorder (OUD). Brixadi is administered in a healthcare setting and is available in weekly or monthly formulations, each at various dosages
Motpoly XR (lacosamide)
Approval Date: May 2023
Indicated for the treatment of partial-onset seizures in adults
Abilify Asimtufii® (aripiprazole)
Approval Date: Apr 2023
Indicated for the treatment of schizophrenia or as maintenance monotherapy treatment of bipolar I disorder
Uzedy™ (risperidone) extended-release injectable suspension
Approval Date: Apr 2023
Indicated for the treatment of schizophrenia in adults
Zavzpret™ (zavegepant) nasal spray
Approval Date: Mar 2023
Indicated for the acute treatment of migraine with or without aura
Combogesic® (acetaminophen and ibuprofen) tablets
Approval Date: Mar 2023
Indicated for the short term management of mild to moderate acute pain
Trokendi XR (topiramate) extended-release capsules
Approval Date: Feb 2023
Indicated for the treatment of partial-onset or primary generalized tonic-clonic seizures, adjunctive therapy for partial-onset, primary generalized tonic-clonic seizures, seizures associated with Lennox-Gastaut syndrome (LGS), and preventive treatment of migraine
Advil Dual Action (acetaminophen and ibuprofen) tablets (OTC)
Approval Date: Feb 2023
Temporarily relieves minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis
Leqembi™ (lecnemab-irmb) injection
Approval Date: Jan 2023
Indicated for the treatment of Alzheimer’s in patients with mild cognitive impairment or mild dementia sage of the disease
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.
Medication Name
Approval Date
Category
Description
Velsipity™ (estrasimod) tablets
Indicated for the treatment of moderate to severe ulcerative colitis
Cosentyx® (secukinumab) injection for intravenous use
Indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, ankylosing spondylitis, and other autoimmune conditions, this drug is now available in an intravenous formulation
Bimzelx® (bimekizumab-bkzx) injection for subcutaneous use
Indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
Combogesic® IV (acetaminophen and ibuprofen)
Indicated for the short term management of mild to moderate acute pain, and the management of moderate to severe pain as an adjunct to opioid analgesics, this drug is now available in an intravenous formulation
Tofidence™ (tocilizumab-bavi) injection
Indicated for the treatment of rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs)
Exxua™ (gepirone) extended-release tablets
Indicated for the treatment of major depressive disorder (MDD), a first-in-class drug that selectively targets the serotonin 1A receptor
Lexette (halobetasol propionate) topical foam
Indicated for the topical treatment of plaque psoriasis
Onglyza™ (saxagliptin) tablets
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Kombiglyze® XR (saxagliptin and metformin hydrochloride) extended-release tablets
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate
RiVive™ (naloxone hydrochloride) nasal spray
Indicated for the emergency treatment of known or suspected opioid overdose, this drug is the second over-the-counter nonprescription opioid overdose drug approved by the FDA
Spiriva® HandiHaler (tiotropium bromide) inhalation powder
For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Katerzia® (amlodipine benzoate) oral suspension
For the treatment of hypertension and coronary artery disease
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.
Diastat® AcuDial (diazepam) rectal gel delivery system
Indicated for the management of selected, refractory, patients with epilepsy, on stable regimens of anti-epileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity
Celontin® (methsuximide) capsules
Indicated for the control of absence (petit mal) seizures that are refractory to other drugs
Yuflyma™ (adalimumab-aaty) injection
A biosimilar to Humira (adalimumab) this drug is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s Disease, ulcerative colitis, and plaque psoriasis
Paxlovid™ (nirmatrelvir and ritonavir) tablets
Indicated for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19
Inpefa™ (sotagliflozin) tablets
Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes
Opvee® (nalmefene hydrochloride) nasal spray
Indicated for the emergency treatment of known or suspected opioid overdose. This is the first approval of nalmefene hydrochloride nasal spray for health care and community use
Brixadi™ (buprenorphine) extended-release injection
Indicated for the treatment of moderate to severe opioid use disorder (OUD). Brixadi is administered in a healthcare setting and is available in weekly or monthly formulations, each at various dosages
Motpoly XR (lacosamide)
Indicated for the treatment of partial-onset seizures in adults
Abilify Asimtufii® (aripiprazole)
Indicated for the treatment of schizophrenia or as maintenance monotherapy treatment of bipolar I disorder
Uzedy™ (risperidone) extended-release injectable suspension
Indicated for the treatment of schizophrenia in adults
Zavzpret™ (zavegepant) nasal spray
Indicated for the acute treatment of migraine with or without aura
Combogesic® (acetaminophen and ibuprofen) tablets
Indicated for the short term management of mild to moderate acute pain
Trokendi XR (topiramate) extended-release capsules
Indicated for the treatment of partial-onset or primary generalized tonic-clonic seizures, adjunctive therapy for partial-onset, primary generalized tonic-clonic seizures, seizures associated with Lennox-Gastaut syndrome (LGS), and preventive treatment of migraine
Advil Dual Action (acetaminophen and ibuprofen) tablets (OTC)
Temporarily relieves minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis
Leqembi™ (lecnemab-irmb) injection
Indicated for the treatment of Alzheimer’s in patients with mild cognitive impairment or mild dementia sage of the disease
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.