Otulfi™ (ustekinumab-aauz)
Approval Date: Sep 2024
A biosimilar to Stelara, this drug is indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe Crohn’s disease, and moderate to severe ulcerative colitis
Relistor® (methylnaltrexone bromide) injection
Approval Date: Aug 2024
Indicated for the treatment of opioid-induced constipation
Zurnai® (nalmefene injection)
Approval Date: Aug 2024
An opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids.
Lucemyra™ (lofexidine) tablets
Approval Date: Aug 2024
Indicated for the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults
Neffy® (epinephrine nasal spray)
Approval Date: Aug 2024
Indicated for the emergency treatment of type I allergic reactions, including anaphylaxis
Tezruly™ (terazosin) oral solution
Approval Date: Jul 2024
Indicated for the treatment of hypertension alone or with other antihypertensive agents, and for the treatment of enlarged prostate
Zunveyl (benzgalantamine) delayed-release tablets
Approval Date: Jul 2024
Indicated for the treatment of mild to moderate dementia of the Alzheimer's type
Olumiant (baricitinib) tablets
Approval Date: Jul 2024
Indicated for the treatment of moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers
Kisunla (donanemab-azbt) injection
Approval Date: Jul 2024
Indicated for the treatment of Alzheimer's disease. Treatment with Kisunla should be initiated in patient with mild cognitive impairment or mild dementia stage of disease, the population in which the treatment was initiated in the clinical trials
Qsymia® (phentermine and topiramate) extended-release tablets
Approval Date: Jun 2024
Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management
Stendra® (avanafil) tablets
Approval Date: Jun 2024
Indicated for the treatment of erectile dysfunction
Pyzchiva® (Ustekinumab-ttwe) injection
Approval Date: Jun 2024
A biosimilar to Stelara; indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis
Chewtadzy™ (tadalafil) chewable tablets
Approval Date: Jun 2024
A new chewable tablet indicated for the treatment of erectile dysfunction, and the signs and symptoms of benign prostatic hyperplasia
Descovy® (emtricitabine and tenofovir alafenamide) tablets
Approval Date: May 2024
Indicated for the treatment of HIV-1 infection, in combination with other antiretroviral agents
Entresto® (sacubitril and valsartan) tablets
Approval Date: May 2024
Indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure
Rezenopy (naloxone hydrochloride) nasal spray
Approval Date: Apr 2024
Indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression
Selarsdi™ (Ustekinumab-aekn) injection
Approval Date: Apr 2024
A biosimilar of Stelara®, this drug is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis
Risvan® (risperidone) for extended-release injectable suspension
Approval Date: Mar 2024
A long-acting, atypical antipsychotic indicated for the treatment of schizophrenia
Winrevair™ (sotatercept-csrk) injections
Approval Date: Mar 2024
A first-in-class biologic indicated for the treatment of pulmonary arterial hypertension to increase exercise capacity and reduce the risk of clinical worsening events
Opsynvi® (macitentan and tadalafil) tablets
Approval Date: Mar 2024
Indicated for the treatment of pulmonary arterial hypertension, both in patients who are treatment naïve or who are already on an ERA, PDE5 inhibitor or both
Tryvio™ (aprocitentan) tablets
Approval Date: Mar 2024
Indicated for the treatment of hypertension in combination with other antihypertensive drugs to lower blood pressure
Simlandi® (adalimumab-ryvk) injection
Approval Date: Feb 2024
A biosimilar to Humira, this drug is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, and plaque psoriasis
Tybost (cobicistat) tablets
Approval Date: Feb 2024
Indicated for the treatment of HIV-1 infection
Dilaudid (hydromorphone hydrochloride) injection
Approval Date: Feb 2024
Indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate
Namzaric® (memantine and donepezil hydrochloride) extended release capsules
Approval Date: Dec 2023
Indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily
Zepbound™ (tirzepatide) injection
Approval Date: Nov 2023
Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in obese adults, or overweight adults with at least one weight-related comorbidity
Zituvimet (sitagliptin and metformin hydrochloride) tablets
Approval Date: Nov 2023
Indicated as an adjunct to diet and exercise to improve glycemic control of type 2 diabetes
Voquezna (vonoprazan fumarate) tablets
Approval Date: Nov 2023
Indicated for erosive esophagitis and the relief of heartburn associated with erosive esophagitis
Zymfentra (infliximab-dyyb) injection
Approval Date: Oct 2023
Indicated for the maintenance treatment of moderate to severe ulcerative colitis or moderate to severe Crohn’s disease, following treatment with an infliximab product administered intravenously
Omvoh (mirikizumab-mrkz) injection
Approval Date: Oct 2023
A first-in-class agent indicated for the treatment of moderate to severe ulcerative colitis
Wezlana™ (ustekinumab-auub) injection
Approval Date: Oct 2023
A biosimilar to Stelara, indicated for the treatment of moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severe Crohn’s disease, and moderate to severe ulcerative colitis
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)
Xeljanz (tofacitinib) oral solution
Approval Date: Sep 2023
Indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis
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
Medication Name
Approval Date
Category
Description
Otulfi™ (ustekinumab-aauz)
A biosimilar to Stelara, this drug is indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe Crohn’s disease, and moderate to severe ulcerative colitis
Relistor® (methylnaltrexone bromide) injection
Indicated for the treatment of opioid-induced constipation
Zurnai® (nalmefene injection)
An opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids.
Lucemyra™ (lofexidine) tablets
Indicated for the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults
Neffy® (epinephrine nasal spray)
Indicated for the emergency treatment of type I allergic reactions, including anaphylaxis
Tezruly™ (terazosin) oral solution
Indicated for the treatment of hypertension alone or with other antihypertensive agents, and for the treatment of enlarged prostate
Zunveyl (benzgalantamine) delayed-release tablets
Indicated for the treatment of mild to moderate dementia of the Alzheimer's type
Olumiant (baricitinib) tablets
Indicated for the treatment of moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers
Kisunla (donanemab-azbt) injection
Indicated for the treatment of Alzheimer's disease. Treatment with Kisunla should be initiated in patient with mild cognitive impairment or mild dementia stage of disease, the population in which the treatment was initiated in the clinical trials
Qsymia® (phentermine and topiramate) extended-release tablets
Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management
Stendra® (avanafil) tablets
Indicated for the treatment of erectile dysfunction
Pyzchiva® (Ustekinumab-ttwe) injection
A biosimilar to Stelara; indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis
Chewtadzy™ (tadalafil) chewable tablets
A new chewable tablet indicated for the treatment of erectile dysfunction, and the signs and symptoms of benign prostatic hyperplasia
Descovy® (emtricitabine and tenofovir alafenamide) tablets
Indicated for the treatment of HIV-1 infection, in combination with other antiretroviral agents
Entresto® (sacubitril and valsartan) tablets
Indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure
Rezenopy (naloxone hydrochloride) nasal spray
Indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression
Selarsdi™ (Ustekinumab-aekn) injection
A biosimilar of Stelara®, this drug is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis
Risvan® (risperidone) for extended-release injectable suspension
A long-acting, atypical antipsychotic indicated for the treatment of schizophrenia
Winrevair™ (sotatercept-csrk) injections
A first-in-class biologic indicated for the treatment of pulmonary arterial hypertension to increase exercise capacity and reduce the risk of clinical worsening events
Opsynvi® (macitentan and tadalafil) tablets
Indicated for the treatment of pulmonary arterial hypertension, both in patients who are treatment naïve or who are already on an ERA, PDE5 inhibitor or both
Tryvio™ (aprocitentan) tablets
Indicated for the treatment of hypertension in combination with other antihypertensive drugs to lower blood pressure
Simlandi® (adalimumab-ryvk) injection
A biosimilar to Humira, this drug is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, and plaque psoriasis
Tybost (cobicistat) tablets
Indicated for the treatment of HIV-1 infection
Dilaudid (hydromorphone hydrochloride) injection
Indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate
Namzaric® (memantine and donepezil hydrochloride) extended release capsules
Indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily
Zepbound™ (tirzepatide) injection
Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in obese adults, or overweight adults with at least one weight-related comorbidity
Zituvimet (sitagliptin and metformin hydrochloride) tablets
Indicated as an adjunct to diet and exercise to improve glycemic control of type 2 diabetes
Voquezna (vonoprazan fumarate) tablets
Indicated for erosive esophagitis and the relief of heartburn associated with erosive esophagitis
Zymfentra (infliximab-dyyb) injection
Indicated for the maintenance treatment of moderate to severe ulcerative colitis or moderate to severe Crohn’s disease, following treatment with an infliximab product administered intravenously
Omvoh (mirikizumab-mrkz) injection
A first-in-class agent indicated for the treatment of moderate to severe ulcerative colitis
Wezlana™ (ustekinumab-auub) injection
A biosimilar to Stelara, indicated for the treatment of moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severe Crohn’s disease, and moderate to severe ulcerative colitis
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)
Xeljanz (tofacitinib) oral solution
Indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis
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