New Drug Approvals Archive for 2022
See also: New Indications and Dosage Forms for 2022
Quviviq (daridorexant) Tablets
Date of Approval: January 7, 2022
Company: Idorsia Ltd.
Treatment for: Insomnia
Quviviq (daridorexant) is a dual orexin receptor antagonist (DORA) for the treatment of insomnia.
Cibinqo (abrocitinib) Tablets
Date of Approval: January 14, 2022
Company: Pfizer Inc.
Treatment for: Atopic Dermatitis
Cibinqo (abrocitinib) is a Janus kinase (JAK) 1 inhibitor for the treatment of moderate-to-severe atopic dermatitis.
Ryaltris (mometasone furoate and olopatadine hydrochloride) Nasal Spray
Date of Approval: January 13, 2022
Company: Glenmark Pharmaceuticals, Inc.
Treatment for: Allergic Rhinitis
Ryaltris (mometasone and olopatadine) nasal spray is a corticosteroid and antihistamine combination for the treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older.
Kimmtrak (tebentafusp-tebn) Injection
Date of Approval: January 25, 2022
Company: Immunocore
Treatment for: Uveal Melanoma
Kimmtrak (tebentafusp-tebn) is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
Vabysmo (faricimab-svoa) Intravitreal Injection
Date of Approval: January 28, 2022
Company: Genentech
Treatment for: Macular Degeneration, Diabetic Macular Edema, Macular Edema
Vabysmo (faricimab-svoa) is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).
Spikevax (Moderna COVID-19 Vaccine) (COVID-19 Vaccine, mRNA) Injection
Date of Approval: January 31, 2022
Company: Moderna, Inc.
Treatment for: Prevention of COVID-19
Spikevax (COVID-19 Vaccine, mRNA) and Moderna COVID-19 Vaccine are mRNA vaccines for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Enjaymo (sutimlimab-jome) Injection
Date of Approval: February 4, 2022
Company: Sanofi
Treatment for: Cold Agglutinin Disease
Enjaymo (sutimlimab-jome) is a classical complement inhibitor indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD).
Fleqsuvy (baclofen) Oral Suspension
Date of Approval: February 4, 2022
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Spasticity
Fleqsuvy (baclofen) is an oral suspension formulation of baclofen for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Pyrukynd (mitapivat) Tablets
Date of Approval: February 17, 2022
Company: Agios Pharmaceuticals, Inc.
Treatment for: Pyruvate Kinase Deficiency
Pyrukynd (mitapivat) is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.
NephroScan (technetium Tc 99m succimer) Injection Kit
Date of Approval: February 22, 2022
Treatment for: Diagnosis and Investigation
NephroScan (kit for the preparation of technetium Tc 99m succimer injection) is a radioactive diagnostic agent indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders.
Carvykti (ciltacabtagene autoleucel) Suspension for Intravenous Infusion
Date of Approval: February 28, 2022
Company: Janssen Pharmaceutical Companies
Treatment for: Multiple Myeloma
Carvykti (ciltacabtagene autoleucel) is a BCMA-directed CAR-T immunotherapy for the treatment of patients with relapsed or refractory multiple myeloma.
Norliqva (amlodipine besylate) Oral Solution
Date of Approval: February 24, 2022
Company: CMP Pharma, Inc.
Treatment for: High Blood Pressure, Coronary Artery Disease, Angina
Norliqva (amlodipine besylate) is an oral solution formulation of the approved calcium channel blocker amlodipine for the treatment of hypertension and angina in patients with coronary artery disease.
Vonjo (pacritinib) Capsules
Date of Approval: February 28, 2022
Company: CTI BioPharma Corp.
Treatment for: Myelofibrosis
Vonjo (pacritinib) is a JAK2/FLT3 multikinase inhibitor for the treatment of myelofibrosis patients with severe thrombocytopenia.
Releuko (filgrastim-ayow) Injection
Date of Approval: February 25, 2022
Company: Kashiv BioSciences, LLC
Treatment for: Neutropenia Associated with Chemotherapy, Neutropenia
Releuko (filgrastim-ayow) is a recombinant human granulocyte colony-stimulating factor biosimilar to Neupogen indicated for the treatment of neutropenia associated with chemotherapy and related conditions.
Adlarity (donepezil) Transdermal System
Date of Approval: March 11, 2022
Company: Corium, Inc.
Treatment for: Alzheimer's Disease
Adlarity (donepezil transdermal system) is a once-weekly transdermal formulation of the approved acetylcholinesterase inhibitor donepezil indicated for the treatment of Alzheimer’s type dementia.
Nasonex 24HR Allergy (mometasone furoate monohydrate) Nasal Spray
Date of Approval: March 17, 2022
Company: Perrigo Company plc
Treatment for: Allergic Rhinitis
Nasonex 24HR Allergy (mometasone furoate monohydrate) is a corticosteroid nasal spray available over-the-counter for the temporary relief of the symptoms of hayfever or other upper respiratory allergies.
Ztalmy (ganaxolone) Oral Suspension
Date of Approval: March 18, 2022
Company: Marinus Pharmaceuticals, Inc.
Treatment for: CDKL5 Deficiency Disorder
Ztalmy (ganaxolone) is neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).
Opdualag (nivolumab and relatlimab-rmbw) Injection
Date of Approval: March 18, 2022
Company: Bristol Myers Squibb
Treatment for: Melanoma
Opdualag (nivolumab and relatlimab-rmbw) is programmed death receptor-1 (PD-1) blocking antibody and lymphocyte activation gene-3 (LAG-3) blocking antibody combination indicated for the treatment of unresectable or metastatic melanoma.
Xelstrym (dextroamphetamine) Transdermal System
Date of Approval: March 22, 2022
Company: Noven Pharmaceuticals, Inc.
Treatment for: ADHD
Xelstrym (dextroamphetamine) transdermal system is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and children 6 years and older.
Locametz (gallium Ga 68 gozetotide) Injection
Date of Approval: March 23, 2022
Company: Novartis Pharmaceuticals Corporation
Treatment for: Positron Emission Tomography Imaging
Locametz (kit for the preparation of gallium Ga 68 gozetotide injection) after radiolabeling with gallium-68, is a radioactive diagnostic agent used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer.
Pluvicto (lutetium lu 177 vipivotide tetraxetan) Injection
Date of Approval: March 23, 2022
Company: Novartis
Treatment for: Prostate Cancer
Pluvicto (lutetium lu 177 vipivotide tetraxetan) is a radioligand therapeutic agent for use in the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
Tlando (testosterone) Capsules
Date of Approval: March 28, 2022
Company: Antares Pharma, Inc.
Treatment for: Hypogonadism, Male
Tlando (testosterone) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Hyftor (sirolimus) Topical Gel
Date of Approval: March 22, 2022
Company: Nobelpharma America, LLC
Treatment for: Facial Angiofibroma Associated with Tuberous Sclerosis
Hyftor (sirolimus topical gel) is an mTOR inhibitor immunosuppressant indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older.
Vijoice (alpelisib) Tablets and Oral Granules
Date of Approval: April 5, 2022
Company: Novartis
Treatment for: PIK3CA-Related Overgrowth Spectrum
Vijoice (alpelisib) is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.
Igalmi (dexmedetomidine) Sublingual Film
Date of Approval: April 5, 2022
Company: BioXcel Therapeutics, Inc.
Treatment for: Agitation
Igalmi (dexmedetomidine) is a sublingual film formulation of the approved alpha2-adrenergic receptor agonist dexmedetomidine indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
Alymsys (bevacizumab-maly) Injection
Date of Approval: April 13, 2022
Company: Amneal Pharmaceuticals, Inc.
Treatment for: Colorectal Cancer, Non Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Alymsys (bevacizumab-maly) is a vascular endothelial growth factor inhibitor biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer including metastatic colorectal cancer; non-small cell lung cancer; glioblastoma; metastatic renal cell carcinoma; cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Epsolay (benzoyl peroxide) Cream
Date of Approval: April 22, 2022
Company: Sol-Gel Technologies, Ltd.
Treatment for: Rosacea
Epsolay (benzoyl peroxide) is a topical oxidizing agent for the treatment of inflammatory lesions of rosacea in adults.
Vivjoa (oteseconazole) Capsules
Date of Approval: April 26, 2022
Company: Mycovia Pharmaceuticals, Inc.
Treatment for: Vaginal Yeast Infection
Vivjoa (oteseconazole) is an oral azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.
Camzyos (mavacamten) Capsules
Date of Approval: April 28, 2022
Company: Bristol Myers Squibb
Treatment for: Hypertrophic Cardiomyopathy
Camzyos (mavacamten) is a first-in-class cardiac myosin inhibitor indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
Cuvrior (trientine tetrahydrochloride) Tablets
Date of Approval: April 28, 2022
Company: Orphalan SA
Treatment for: Wilson's Disease
Cuvrior (trientine tetrahydrochloride) is a copper chelator indicated for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine.
Voquezna Triple Pak (amoxicillin, clarithromycin, and vonoprazan) Co-Packaged Capsules and Tablets
Date of Approval: May 3, 2022
Company: Phathom Pharmaceuticals, Inc.
Treatment for: Helicobacter Pylori Infection
Voquezna Triple Pak (amoxicillin, clarithromycin, and vonoprazan) is a co-packaged product containing amoxicillin (penicillin class antibacterial), clarithromycin (macrolide antimicrobial), and vonoprazan (potassium-competitive acid blocker (PCAB)) indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults.
Radicava ORS (edaravone) Oral Suspension
Date of Approval: May 12, 2022
Company: Mitsubishi Tanabe Pharma Corporation
Treatment for: Amyotrophic Lateral Sclerosis
Radicava ORS is a free radical scavenger indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Mounjaro (tirzepatide) Injection
Date of Approval: May 13, 2022
Company: Eli Lilly and Company
Treatment for: Type 2 Diabetes
Mounjaro (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Vtama (tapinarof) Cream
Date of Approval: May 23, 2022
Company: Organon
Treatment for: Plaque Psoriasis, Atopic Dermatitis
Vtama (tapinarof) is a topical aryl hydrocarbon receptor (AhR) modulating agent used for the treatment of plaque psoriasis and atopic dermatitis.
Fylnetra (pegfilgrastim-pbbk) Injection
Date of Approval: May 26, 2022
Company: Amneal Pharmaceuticals, Inc.
Treatment for: Neutropenia Associated with Chemotherapy
Fylnetra (pegfilgrastim-pbbk) is a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim) used to reduce the incidence of neutropenia in patients undergoing chemotherapy.
Priorix (measles, mumps, and rubella virus vaccine, live) Injection
Date of Approval: June 3, 2022
Company: GSK
Treatment for: Measles Prophylaxis, Mumps Prophylaxis, Rubella Prophylaxis
Priorix (measles, mumps, and rubella virus vaccine, live) is a live attenuated vaccine for use in active immunization against infection by measles, mumps and rubella (MMR).
Amvuttra (vutrisiran) Injection
Date of Approval: June 13, 2022
Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Hereditary Amyloidosis, Cardiomyopathy of Transthyretin-Mediated Amyloidosis
Amvuttra (vutrisiran) is an RNAi therapeutic for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis and cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis.
Bludigo (indigotindisulfonate sodium) Injection
Date of Approval: July 8, 2022
Company: Provepharm
Treatment for: Diagnosis and Investigation
Bludigo (indigotindisulfonate sodium) is a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures.
Zonisade (zonisamide) Oral Suspension
Date of Approval: July 15, 2022
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Seizures
Zonisade (zonisamide) is an oral suspension formulation of the approved anticonvulsant zonisamide indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older.
Zoryve (roflumilast) Cream and Foam
Date of Approval: July 29, 2022
Company: Arcutis Biotherapeutics, Inc.
Treatment for: Plaque Psoriasis, Atopic Dermatitis, Seborrheic Dermatitis
Zoryve (roflumilast) is a topical phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of plaque psoriasis (0.3% cream formulation), atopic dermatitis (0.15% cream formulation) and seborrheic dermatitis (0.3% foam formulation).
Kyzatrex (testosterone undecanoate) Capsules
Date of Approval: July 27, 2022
Company: Marius Pharmaceuticals
Treatment for: Hypogonadism, Male
Kyzatrex (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.
Cimerli (ranibizumab-eqrn) Intravitreal Injection
Date of Approval: August 2, 2022
Company: Coherus BioSciences, Inc.
Treatment for: Macular Degeneration, Macular Edema, Diabetic Macular Edema, Diabetic Retinopathy, Myopic Choroidal Neovascularization
Cimerli (ranibizumab-eqrn) is a vascular endothelial growth factor (VEGF) inhibitor, interchangeable biosimilar to Lucentis indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).
Zynteglo (betibeglogene autotemcel) Suspension for Intravenous Infusion
Date of Approval: August 17, 2022
Company: Bluebird Bio, Inc.
Treatment for: Beta Thalassemia
Zynteglo (betibeglogene autotemcel) is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions.
Auvelity (dextromethorphan and bupropion) Extended-Release Tablets - formerly AXS-05
Date of Approval: August 18, 2022
Company: Axsome Therapeutics, Inc.
Treatment for: Major Depressive Disorder
Auvelity (dextromethorphan and bupropion) is an NMDA receptor antagonist for the treatment of major depressive disorder (MDD) in adults.
Xenpozyme (olipudase alfa) Lyophilized Powder for Injection
Date of Approval: August 31, 2022
Company: Sanofi
Treatment for: Acid Sphingomyelinase Deficiency
Xenpozyme (olipudase alfa-rpcp) is a hydrolytic lysosomal sphingomyelin-specific enzyme indicated for the treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD).
Konvomep (omeprazole and sodium bicarbonate) Powder for Oral Suspension
Date of Approval: August 30, 2022
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Stomach Ulcer, Gastrointestinal Hemorrhage
Konvomep (omeprazole and sodium bicarbonate) is an oral liquid formulation of the proton pump inhibitor (PPI) omeprazole and sodium bicarbonate combination indicated for the treatment of active benign gastric ulcer, and reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients.
Spevigo (spesolimab-sbzo) Injection
Date of Approval: September 1, 2022
Company: Boehringer Ingelheim
Treatment for: Generalized Pustular Psoriasis
Spevigo (spesolimab-sbzo) is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis.
Stimufend (pegfilgrastim-fpgk) Injection
Date of Approval: September 1, 2022
Company: Fresenius Kabi
Treatment for: Neutropenia Associated with Chemotherapy, Neutropenia Associated with Radiation, Hematopoietic Syndrome of Acute Radiation Syndrome
Stimufend (pegfilgrastim-fpgk) is a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim) used to reduce the duration of febrile neutropenia in patients treated with chemotherapy and to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
Daxxify (daxibotulinumtoxinA-lanm) Lyophilized Powder for Injection
Date of Approval: September 7, 2022
Company: Revance Therapeutics, Inc.
Treatment for: Glabellar Lines, Cervical Dystonia
Daxxify (daxibotulinumtoxinA-lanm) is an acetylcholine release inhibitor and neuromuscular blocking agent for the temporary improvement of glabellar (frown) lines and the treatment of cervical dystonia.
Sotyktu (deucravacitinib) Tablets
Date of Approval: September 9, 2022
Company: Bristol Myers Squibb
Treatment for: Plaque Psoriasis
Sotyktu (deucravacitinib) is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Rolvedon (eflapegrastim-xnst) Injection - formerly Rolontis
Date of Approval: September 9, 2022
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Neutropenia Associated with Chemotherapy
Rolvedon (eflapegrastim-xnst) is a leukocyte growth factor used to reduce the incidence of infection due to chemotherapy-induced neutropenia.
Terlivaz (terlipressin) Lyophilized Powder for Injection
Date of Approval: September 14, 2022
Company: Mallinckrodt plc
Treatment for: Hepatorenal Syndrome
Terlivaz (terlipressin) is a vasopressin receptor agonist indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function.
Aponvie (aprepitant) Injection - formerly HTX-019
Date of Approval: September 16, 2022
Company: Heron Therapeutics, Inc.
Treatment for: Nausea/Vomiting, Postoperative
Aponvie (aprepitant) is an intravenous formulation of the approved antiemetic aprepitant indicated for the prevention of postoperative nausea and vomiting (PONV).
Skysona (elivaldogene autotemcel) Suspension for Intravenous Infusion
Date of Approval: September 16, 2022
Company: bluebird bio, Inc.
Treatment for: Cerebral Adrenoleukodystrophy
Skysona (elivaldogene autotemcel) is a one-time gene therapy used to treat the underlying cause of cerebral adrenoleukodystrophy (CALD).
Elucirem (gadopiclenol) Injection
Date of Approval: September 21, 2022
Company: Guerbet
Treatment for: Diagnosis and Investigation
Elucirem (gadopiclenol) is a macrocyclic gadolinium-based contrast agent (GBCA) for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the CNS and the body.
Pedmark (sodium thiosulfate) Injection
Date of Approval: September 20, 2022
Company: Fennec Pharmaceuticals Inc.
Treatment for: Prevention of Cisplatin-Induced Ototoxicity
Pedmark (sodium thiosulfate) is a cisplatin neutralizing agent used to reduce the risk of ototoxicity associated with cisplatin chemotherapy.
Omlonti (omidenepag isopropyl) Ophthalmic Solution
Date of Approval: September 22, 2022
Company: Santen Inc.
Treatment for: Glaucoma/Intraocular Hypertension
Omlonti (omidenepag isopropyl) is a relatively selective prostaglandin E2 (EP2) receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Iheezo (chloroprocaine hydrochloride) Ophthalmic Gel
Date of Approval: September 27, 2022
Company: Harrow
Treatment for: Ocular Surface Anesthesia
Iheezo (chloroprocaine hydrochloride) is an ester anesthetic indicated for ocular surface anesthesia.
Vegzelma (bevacizumab-adcd) Injection
Date of Approval: September 27, 2022
Company: Celltrion USA
Treatment for: Colorectal Cancer, Non Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Vegzelma (bevacizumab-adcd) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer including colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Relyvrio (sodium phenylbutyrate and taurursodiol) Powder for Oral Suspension - formerly AMX0035
Date of Approval: September 29, 2022
Company: Amylyx Pharmaceuticals, Inc.
Treatment for: Amyotrophic Lateral Sclerosis
Relyvrio (sodium phenylbutyrate and taurursodiol) is a neuroprotective therapy for the treatment of amyotrophic lateral sclerosis (ALS).
Lytgobi (futibatinib) Tablets
Date of Approval: September 30, 2022
Company: Taiho Oncology, Inc.
Treatment for: Cholangiocarcinoma
Lytgobi (futibatinib) is an irreversible tyrosine kinase inhibitor of FGFR1, 2, 3 and 4 for the treatment of intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.
Furoscix (furosemide) Injection
Date of Approval: October 7, 2022
Company: scPharmaceuticals, Inc.
Treatment for: Heart Failure, Chronic Kidney Disease
Furoscix (furosemide) is a loop diuretic indicated for the at-home treatment of edema in adult patients with chronic heart failure or chronic kidney disease.
Imjudo (tremelimumab-actl) Injection
Date of Approval: October 21, 2022
Company: AstraZeneca
Treatment for: Hepatocellular Carcinoma, Non Small Cell Lung Cancer
Imjudo (tremelimumab-actl) is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated in combination with durvalumab (Imfinzi) for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC), and in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Tecvayli (teclistamab-cqyv) Injection
Date of Approval: October 25, 2022
Company: Janssen Pharmaceutical Companies of Johnson & Johnson
Treatment for: Multiple Myeloma
Tecvayli (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
Elahere (mirvetuximab soravtansine-gynx) Injection
Date of Approval: November 14, 2022
Company: AbbVie Inc.
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Elahere (mirvetuximab soravtansine-gynx) is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
Tzield (teplizumab-mzwv) Injection
Date of Approval: November 17, 2022
Company: Provention Bio, Inc.
Treatment for: Delaying the Onset of Stage 3 Type 1 Diabetes
Tzield (teplizumab-mzwv) is a CD3-directed antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.
Sezaby (phenobarbital sodium) Powder for Injection
Date of Approval: November 17, 2022
Company: Sun Pharmaceutical Industries Limited
Treatment for: Neonatal Seizures
Sezaby (phenobarbital sodium) is a barbiturate indicated for the treatment of neonatal seizures in term and preterm infants.
Hemgenix (etranacogene dezaparvovec-drlb) Suspension for Intravenous Infusion
Date of Approval: November 22, 2022
Company: CSL
Treatment for: Hemophilia B
Hemgenix (etranacogene dezaparvovec-drlb) is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with hemophilia B.
Rebyota (fecal microbiota, live-jslm) Suspension for Rectal Use - formerly RBX2660
Date of Approval: November 30, 2022
Company: Ferring Pharmaceuticals Inc.
Treatment for: Prevention of Recurrent Clostridioides difficile Infection
Rebyota (fecal microbiota, live-jslm) is a microbiota-based live biotherapeutic indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.
Rezlidhia (olutasidenib) Capsules
Date of Approval: December 1, 2022
Company: Forma Therapeutics
Treatment for: Acute Myeloid Leukemia
Rezlidhia (olutasidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
Krazati (adagrasib) Tablets
Date of Approval: December 12, 2022
Company: Mirati Therapeutics, Inc.
Treatment for: Non Small Cell Lung Cancer, Colorectal Cancer
Krazati (adagrasib) is a small-molecule inhibitor of KRAS G12C for the treatment of adult patients with KRAS G12C-mutated non-small cell lung cancer and KRAS G12C-mutated colorectal cancer.
Iyuzeh (latanoprost) Ophthalmic Solution
Date of Approval: December 13, 2022
Company: Thea Pharma, Inc.
Treatment for: Intraocular Hypertension, Glaucoma, Open Angle
Iyuzeh (latanoprost) is a prostaglandin F2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Idacio (adalimumab-aacf) Injection
Date of Approval: December 13, 2022
Company: Fresenius Kabi
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis
Idacio (adalimumab-aacf) is a tumor necrosis factor (TNF) blocker biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
Adstiladrin (nadofaragene firadenovec-vncg) Suspension for Intravesical Use
Date of Approval: December 16, 2022
Company: Ferring Pharmaceuticals
Treatment for: Bladder Cancer
Adstiladrin (nadofaragene firadenovec-vncg) is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus CalmetteGuérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
Sunlenca (lenacapavir) Injection and Tablets
Date of Approval: December 22, 2022
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection
Sunlenca (lenacapavir) is a long-acting HIV-1 capsid inhibitor for use in combination with other antiretroviral(s) for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.
Lunsumio (mosunetuzumab-axgb) Injection
Date of Approval: December 22, 2022
Company: Genentech
Treatment for: Follicular Lymphoma
Lunsumio (mosunetuzumab-axgb) is a bispecific CD20-directed CD3 T-cell engager for the treatment of relapsed or refractory follicular lymphoma.
Olpruva (sodium phenylbutyrate) for Oral Suspension - formerly ACER-001
Date of Approval: December 22, 2022
Company: Acer Therapeutics Inc.
Treatment for: Urea Cycle Disorders
Olpruva (sodium phenylbutyrate) is a nitrogen-binding agent for the treatment of patients with urea cycle disorders (UCDs).
Xenoview (xenon Xe 129 hyperpolarized) for Oral Inhalation
Date of Approval: December 23, 2022
Company: Polarean Imaging plc
Treatment for: Diagnosis and Investigation, Imaging of Lung
Xenoview (xenon Xe 129 hyperpolarized) is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.
Briumvi (ublituximab-xiiy) Injection
Date of Approval: December 28, 2022
Company: TG Therapeutics, Inc.
Treatment for: Multiple Sclerosis
Briumvi (ublituximab-xiiy) is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults.
NexoBrid (anacaulase-bcdb) Lyophilized Powder for Topical Gel
Date of Approval: December 28, 2022
Company: Vericel Corporation
Treatment for: Thermal Burns
NexoBrid (anacaulase-bcdb) is a concentrate of proteolytic enzymes indicated for eschar removal in adult and pediatric patients with deep partial thickness and/or full thickness thermal burns.
Vigpoder (vigabatrin) for Oral Solution
Date of Approval: June 24, 2022
Company: Pyros Pharmaceuticals, Inc.
Treatment for: Seizures, Infantile Spasms
Vigpoder (vigabatrin) is an anticonvulsant used for the treatment of refractory complex partial seizures and infantile spasms.
New drug approvals archive
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.