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New Drug Approvals Archive for 2021

See also: New Indications and Dosage Forms for 2021

Astepro Allergy (azelastine) Nasal Spray

Date of Approval: June 17, 2021
Company: Bayer HealthCare LLC
Treatment for: Allergic Rhinitis

Astepro Allergy (azelastine) is a nasal antihistamine for the treatment of seasonal allergic rhinitis.

Verquvo (vericiguat) Tablets

Date of Approval: January 19, 2021
Company: Merck
Treatment for: Heart Failure with Reduced Ejection Fraction (HFrEF)

Verquvo (vericiguat) is a soluble guanylate cyclase (sGC) stimulator indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

Cabenuva (cabotegravir and rilpivirine) Extended-Release Injectable Suspension ( Co-Packaged)

Date of Approval: January 21, 2021
Company: ViiV Healthcare
Treatment for: HIV Infection

Cabenuva (cabotegravir and rilpivirine) is a long-acting, injectable regimen of the HIV-1 integrase strand transfer inhibitor (INSTI) cabotegravir, and the HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older.

Lupkynis (voclosporin) Capsules

Date of Approval: January 22, 2021
Company: Aurinia Pharmaceuticals Inc.
Treatment for: Lupus Nephritis

Lupkynis (voclosporin) is a calcineurin-inhibitor immunosuppressant indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN).

Posimir (bupivacaine) Solution for Infiltration Use

Date of Approval: February 1, 2021
Company: Durect Corporation
Treatment for: Post-Surgical Pain

Posimir (bupivacaine) is a sustained-release anamide local anesthetic formulation indicated for post-surgical pain reduction following arthroscopic subacromial decompression shoulder surgery.

Tepmetko (tepotinib) Tablets

Date of Approval: February 3, 2021
Company: EMD Serono, Inc.
Treatment for: Non-Small Cell Lung Cancer

Tepmetko (tepotinib) is an oral MET inhibitor for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

Ukoniq (umbralisib) Tablets

Date of Approval: February 5, 2021
Company: TG Therapeutics, Inc.
Treatment for: Marginal Zone Lymphoma; Follicular Lymphoma

Ukoniq (umbralisib) is a dual inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon for the treatment of marginal zone lymphoma (MZL) and follicular Lymphoma (FL).

Breyanzi (lisocabtagene maraleucel) Suspension for Intravenous Infusion

Date of Approval: February 5, 2021
Company: Bristol-Myers Squibb Company
Treatment for: Large B-Cell Lymphoma

Breyanzi (lisocabtagene maraleucel) is a CD-19 directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL).

Evkeeza (evinacumab-dgnb) Injection

Date of Approval: February 11, 2021
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: High Cholesterol, Familial Homozygous

Evkeeza (evinacumab-dgnb) is an angiopoietin-like 3 (ANGPTL3) inhibitor indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH).

Cosela (trilaciclib) for Injection

Date of Approval: February 12, 2021
Company: G1 Therapeutics, Inc.
Treatment for: Small Cell Lung Cancer Myelopreservation Therapy

Cosela (trilaciclib) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor myelopreservation therapy for use in patients with small cell lung cancer (SCLC) who are receiving chemotherapy.

Amondys 45 (casimersen) Injection

Date of Approval: February 25, 2021
Company: Sarepta Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy

Amondys 45 (casimersen) is an antisense oligonucleotide for the treatment of patients with Duchenne muscular dystrophy (DMD) who have genetic mutations that are amenable to skipping exon 45 of the Duchenne gene.

Pepaxto (melphalan flufenamide) Injection

Date of Approval: February 26, 2021
Company: Oncopeptides AB
Treatment for: Multiple Myeloma

Pepaxto (melphalan flufenamide) is an anticancer peptide-drug conjugate indicated for use in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma.

Nulibry (fosdenopterin) Injection

Date of Approval: February 26, 2021
Company: BridgeBio Pharma, Inc.
Treatment for: Molybdenum Cofactor Deficiency (MoCD) Type A

Nulibry (fosdenopterin) is a cyclic pyranopterin monophosphate (cPMP) substrate replacement therapy for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

Azstarys (dexmethylphenidate and serdexmethylphenidate) Capsules

Date of Approval: March 2, 2021
Company: KemPharm, Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Azstarys (dexmethylphenidate and serdexmethylphenidate) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.

Fotivda (tivozanib) Capsules

Date of Approval: March 10, 2021
Company: AVEO Oncology
Treatment for: Renal Cell Carcinoma

Fotivda (tivozanib) is a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

Kimyrsa (oritavancin) for Injection

Date of Approval: March 12, 2021
Company: Melinta Therapeutics, LLC
Treatment for: Skin and Structure Infection

Kimyrsa (oritavancin) is a lipoglycopeptide antibiotic for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSI) caused by designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA).

Ponvory (ponesimod) Tablets

Date of Approval: March 18, 2021
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Multiple Sclerosis

Ponvory (ponesimod) is a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator indicated for the treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Zegalogue (dasiglucagon) Injection

Date of Approval: March 22, 2021
Company: Zealand Pharma A/S
Treatment for: Hypoglycemia

Zegalogue (dasiglucagon) is a glucagon analog antihypoglycemic agent for the treatment of severe hypoglycemia in diabetes patients aged 6 years and older.

Abecma (idecabtagene vicleucel) Suspension for Intravenous Infusion

Date of Approval: March 26, 2021
Company: Bristol Myers Squibb
Treatment for: Multiple Myeloma

Abecma (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Roszet (ezetimibe and rosuvastatin) Tablets

Date of Approval: March 23, 2021
Company: Althera Life Sciences, LLC
Treatment for: High Cholesterol, High Cholesterol, Familial Homozygous

Roszet (ezetimibe and rosuvastatin) is an intestinal cholesterol inhibitor and HMG Co-A reductase inhibitor (statin) combination indicated to reduce low-density lipoprotein cholesterol (LDL-C) in primary non-familial hyperlipidemia and homozygous familial hypercholesterolemia (HoFH).

Qelbree (viloxazine hydrochloride) Extended Release Capsules

Date of Approval: April 2, 2021
Company: Supernus Pharmaceuticals, Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Qelbree (viloxazine hydrochloride) is a serotonin norepinephrine modulating agent (SNMA) for the treatment of attention deficit hyperactivity disorder (ADHD) in in adults and pediatric patients 6 years and older.

Nextstellis (drospirenone and estetrol) Tablets

Date of Approval: April 15, 2021
Company: Mayne Pharma
Treatment for: Birth Control

Nextstellis (drospirenone and estetrol) is a progestin and estrogen combination indicated for use by females of reproductive potential to prevent pregnancy.

Jemperli (dostarlimab-gxly) Injection

Date of Approval: April 22, 2021
Company: GlaxoSmithKline
Treatment for: Endometrial Cancer, Solid Tumors

Jemperli (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)–blocking antibody for the treatment of mismatch repair deficient (dMMR) endometrial cancer, and dMMR solid tumors.

Zynlonta (loncastuximab tesirine-lpyl) Injection

Date of Approval: April 23, 2021
Company: ADC Therapeutics SA
Treatment for: Diffuse Large B-cell Lymphoma

Zynlonta (loncastuximab tesirine-lpyl) is a CD19-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.

Kloxxado (naloxone hydrochloride) Nasal Spray

Date of Approval: April 30, 2021
Company: Hikma Pharmaceuticals PLC
Treatment for: Opioid Overdose

Kloxxado (naloxone hydrochloride) nasal spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.

Zynrelef (bupivacaine and meloxicam) Injection

Date of Approval: May 12, 2021
Company: Heron Therapeutics, Inc.
Treatment for: Postoperative Pain

Zynrelef (bupivacaine and meloxicam) is an extended-release, fixed-dose combination of the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam indicated for the management of postoperative pain.

Empaveli (pegcetacoplan) Injection

Date of Approval: May 14, 2021
Company: Apellis Pharmaceuticals, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria

Empaveli (pegcetacoplan) is a targeted C3 inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Rybrevant (amivantamab-vmjw) Injection

Date of Approval: May 21, 2021
Company: The Janssen Pharmaceutical Companies of Johnson & Johnson
Treatment for: Non-Small Cell Lung Cancer

Rybrevant (amivantamab-vmjw) is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.

Camcevi (leuprolide mesylate) Injection

Date of Approval: May 26, 2021
Company: Foresee Pharmaceuticals
Treatment for: Prostate Cancer

Camcevi (leuprolide mesylate) is a ready-to-use, 6-month depot formulation of the approved gonadotropin releasing hormone (GnRH) agonist leuprolide indicated for the treatment of adult patients with advanced prostate cancer.

Myfembree (relugolix, estradiol and norethindrone acetate) Tablets

Date of Approval: May 26, 2021
Company: Myovant Sciences
Treatment for: Uterine Fibroids, Endometriosis

Myfembree (relugolix, estradiol and norethindrone acetate) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, estrogen, and progestin combination indicated in premenopausal women for the management of heavy menstrual bleeding associated with uterine fibroids, and moderate to severe pain associated with endometriosis.

Pylarify (piflufolastat F 18) Injection

Date of Approval: May 26, 2021
Company: Progenics Pharmaceuticals, Inc.
Treatment for: Positron Emission Tomography Imaging

Pylarify (piflufolastat F 18) is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Truseltiq (infigratinib) Capsules

Date of Approval: May 28, 2021
Company: BridgeBio Pharma, Inc.
Treatment for: Cholangiocarcinoma

Truseltiq (infigratinib) is an FGFR tyrosine kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

Lumakras (sotorasib) Tablets

Date of Approval: May 28, 2021
Company: Amgen Inc.
Treatment for: Non-Small Cell Lung Cancer

Lumakras (sotorasib) is a KRASG12C inhibitor for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non- small cell lung cancer (NSCLC), following at least one prior systemic therapy.

Lybalvi (olanzapine and samidorphan) Tablets

Date of Approval: May 28, 2021
Company: Alkermes plc
Treatment for: Schizophrenia, Bipolar Disorder

Lybalvi (olanzapine and samidorphan) is a combination of an established antipsychotic agent (olanzapine) and a novel μ-opioid receptor antagonist (samidorphan) for the treatment of schizophrenia and bipolar I disorder.

Brexafemme (ibrexafungerp) Tablets

Date of Approval: June 1, 2021
Company: Scynexis, Inc.
Treatment for: Vaginal Yeast Infection

Brexafemme (ibrexafungerp) is a first-in-class, triterpenoid antifungal agent for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC).

Wegovy (semaglutide) Injection

Date of Approval: June 4, 2021
Company: Novo Nordisk
Treatment for: Obesity

Wegovy (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise for chronic weight management in adult patients who are overweight (BMI ≥27 kg/m2) or obese (BMI ≥30 kg/m2).

Ryplazim (plasminogen, human-tvmh) Injection

Date of Approval: June 4, 2021
Company: Liminal BioSciences Inc.
Treatment for: Plasminogen Deficiency Type 1

Ryplazim (plasminogen, human-tvmh) is a plasma-derived plasminogen replacement therapy for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenia).

Tembexa (brincidofovir) Tablets and Oral Suspension

Date of Approval: June 4, 2021
Company: Chimerix, Inc.
Treatment for: Smallpox

Tembexa (brincidofovir) is a nucleotide analog broad-spectrum antiviral indicated for use as a medical countermeasure for smallpox.

Aduhelm (aducanumab-avwa) Injection

Date of Approval: June 7, 2021
Company: Biogen
Treatment for: Alzheimer's Disease

Aduhelm (aducanumab-avwa) is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.

Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Prevnar 20 (pneumococcal 20-valent conjugate vaccine) Injection

Date of Approval: June 8, 2021
Company: Pfizer Inc.
Treatment for: Pneumococcal Disease Prophylaxis

Prevnar 20 (pneumococcal 20-valent conjugate vaccine) is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older.

Rezipres (ephedrine hydrochloride) Injection

Date of Approval: June 14, 2021
Company: Eton Pharmaceuticals, Inc.
Treatment for: Hypotension

Rezipres (ephedrine hydrochloride) is an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.

Astepro Allergy (azelastine) Nasal Spray

Date of Approval: June 17, 2021
Company: Bayer HealthCare LLC
Treatment for: Allergic Rhinitis

Astepro Allergy (azelastine) is a nasal antihistamine for the treatment of seasonal allergic rhinitis.

Soaanz (torsemide) Tablets

Date of Approval: June 14, 2021
Company: Sarfez Pharmaceuticals
Treatment for: Edema

Soaanz (torsemide) is a loop diuretic indicated for the treatment of edema associated with heart failure or renal disease in adults.

Verkazia (cyclosporine) Ophthalmic Emulsion

Date of Approval: June 23, 2021
Company: Santen Inc.
Treatment for: Vernal Keratoconjunctivitis

Verkazia (cyclosporine) is a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults.

Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) Injection

Date of Approval: June 30, 2021
Company: Jazz Pharmaceuticals plc
Treatment for: Acute Lymphoblastic Leukemia

Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL).

Kerendia (finerenone) Tablets

Date of Approval: July 9, 2021
Company: Bayer
Treatment for: Chronic Kidney Disease Associated with Type 2 Diabetes

Kerendia (finerenone) is a non-steroidal, selective mineralocorticoid receptor antagonist (MRA) for the treatment of patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

Rezurock (belumosudil) Tablets

Date of Approval: July 16, 2021
Company: Kadmon Holdings, Inc.
Treatment for: Graft-versus-host disease

Rezurock (belumosudil) is a kinase inhibitor for the treatment of patients with chronic graft-versus-host disease (cGVHD).

Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Injection

Date of Approval: July 16, 2021
Company: Merck
Treatment for: Pneumococcal Disease Prophylaxis

Vaxneuvance (pneumococcal 15-valent conjugate vaccine) is a vaccine indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older.

(fexinidazole) Tablets

Date of Approval: July 16, 2021
Company: Drugs for Neglected Diseases Initiative
Treatment for: Trypanosomiasis

Fexinidazole is a nitroimidazole antibacterial indicated for the treatment of human African trypanosomiasis (African sleeping sickness) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg.

Bylvay (odevixibat) Capsules

Date of Approval: July 20, 2021
Company: Albireo Pharma, Inc.
Treatment for: Progressive Familial Intrahepatic Cholestasis (PFIC)

Bylvay (odevixibat) is an ileal bile acid transport (IBAT) inhibitor for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).

Twyneo (tretinoin and benzoyl peroxide) Cream

Date of Approval: July 26, 2021
Company: Sol-Gel Technologies, Ltd.
Treatment for: Acne

Twyneo (tretinoin and benzoyl peroxide) is a topical retinoid and antibacterial fixed-dose combination for the treatment of acne vulgaris in adults and children 9 years of age and older.

Saphnelo (anifrolumab-fnia) Injection

Date of Approval: July 30, 2021
Company: AstraZeneca
Treatment for: Systemic Lupus Erythematosus

Saphnelo (anifrolumab) is a type I interferon (IFN) receptor antagonist indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.

Nexviazyme (avalglucosidase alfa-ngpt) Lyophilized Powder for Injection

Date of Approval: August 6, 2021
Company: Sanofi
Treatment for: Pompe disease

Nexviazyme (avalglucosidase alfa-ngpt) is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients with late-onset Pompe disease.

TicoVac (tick-borne encephalitis vaccine) Injection

Date of Approval: August 13, 2021
Company: Pfizer Inc.
Treatment for: Tick-Borne Encephalitis Prophylaxis

TicoVac (tick-borne encephalitis vaccine) is an inactivated whole virus vaccine indicated for active immunization to prevent tick-borne encephalitis (TBE) in individuals 1 year of age and older.

Welireg (belzutifan) Tablets

Date of Approval: August 13, 2021
Company: Merck
Treatment for: Von Hippel-Lindau Syndrome

Welireg (belzutifan) is a selective inhibitor of hypoxia-inducible factor 2 alpha (HIF-2α) for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

Comirnaty (COVID-19 Vaccine, mRNA) Injection

Date of Approval: August 23, 2021
Company: Pfizer Inc. and BioNTech SE
Treatment for: Prevention of COVID-19

Comirnaty is an mRNA vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Korsuva (difelikefalin) Injection

Date of Approval: August 23, 2021
Company: Cara Therapeutics, Inc.
Treatment for: Chronic Kidney Disease-Associated Pruritus

Korsuva (difelikefalin) is a selective peripheral kappa opioid receptor agonist indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).

Skytrofa (lonapegsomatropin-tcgd) for Injection

Date of Approval: August 25, 2021
Company: Ascendis Pharma A/S
Treatment for: Pediatric Growth Hormone Deficiency

Skytrofa (lonapegsomatropin-tcgd) is a human growth hormone used once-weekly for the treatment of pediatric growth hormone deficiency.

Invega Hafyera (paliperidone palmitate) Extended-Release Injectable Suspension

Date of Approval: August 30, 2021
Company: Janssen Pharmaceutical Companies of Johnson & Johnson
Treatment for: Schizophrenia

Invega Hafyera (paliperidone palmitate) is a long-acting injectable atypical antipsychotic for the twice-yearly treatment of schizophrenia in adults.

Trudhesa (dihydroergotamine mesylate) Nasal Spray

Date of Approval: September 2, 2021
Company: Impel NeuroPharma, Inc.
Treatment for: Migraine

Trudhesa (dihydroergotamine mesylate) is a nasally administered dihydroergotamine (DHE) formulation for the acute treatment of migraine with or without aura in adults.

Exkivity (mobocertinib) Capsules

Date of Approval: September 15, 2021
Company: Takeda Pharmaceutical Company Limited
Treatment for: Non-Small Cell Lung Cancer

Exkivity (mobocertinib) is an oral tyrosine kinase inhibitor for the treatment of patients with epidermal growth factor receptor (EGFR) exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC).

Byooviz (ranibizumab-nuna) Intravitreal Injection

Date of Approval: September 17, 2021
Company: Samsung Bioepis Co., Ltd.
Treatment for: Macular Degeneration, Macular Edema, Myopic Choroidal Neovascularization

Byooviz (ranibizumab-nuna) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Lucentis indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

Tivdak (tisotumab vedotin-tftv) Lyophilized Powder for Injection

Date of Approval: September 20, 2021
Company: Seagen Inc.
Treatment for: Cervical Cancer

Tivdak (tisotumab vedotin-tftv) is a tissue factor-directed antibody and microtubule inhibitor conjugate for the treatment of patients with recurrent or metastatic cervical cancer.

Opzelura (ruxolitinib) Cream

Date of Approval: September 21, 2021
Company: Incyte
Treatment for: Atopic Dermatitis, Vitiligo

Opzelura (ruxolitinib) cream is a topical Janus kinase (JAK) inhibitor used for the treatment of atopic dermatitis and nonsegmental vitiligo.

Qulipta (atogepant) Tablets

Date of Approval: September 28, 2021
Company: AbbVie Inc.
Treatment for: Migraine Prevention

Qulipta (atogepant) is an oral, calcitonin gene-related peptide (CGRP) receptor antagonist indicated for the preventive treatment of episodic migraine in adults.

Livmarli (maralixibat) Oral Solution

Date of Approval: September 29, 2021
Company: Mirum Pharmaceuticals, Inc.
Treatment for: Cholestatic Pruritus in Alagille Syndrome

Livmarli (maralixibat) is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older.

Rethymic (allogeneic processed thymus tissue-agdc) for Surgical Implantation

Date of Approval: October 8, 2021
Company: Enzyvant Therapeutics, Inc.
Treatment for: Congenital Athymia

Rethymic (allogeneic processed thymus tissue-agdc) is a one-time regenerative tissue-based therapy indicated for immune reconstitution in pediatric patients with congenital athymia.

Tavneos (avacopan) Capsules

Date of Approval: October 7, 2021
Company: ChemoCentryx, Inc.
Treatment for: ANCA-Associated Vasculitis

Tavneos (avacopan) is a complement 5a receptor (C5aR) antagonist for the adjunctive treatment of anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.

Zimhi (naloxone hydrochloride) Injection

Date of Approval: October 15, 2021
Company: Adamis Pharmaceuticals Corporation
Treatment for: Opioid Overdose

Zimhi (naloxone hydrochloride) is a high-dose formulation of the approved opioid antagonist naloxone for use in the treatment of opioid overdose.

Seglentis (celecoxib and tramadol hydrochloride) Tablets

Date of Approval: October 15, 2021
Company: Esteve Pharmaceuticals, S.A.
Treatment for: Pain

Seglentis (celecoxib and tramadol hydrochloride) is a nonsteroidal anti-inflammatory drug (NSAID) and opioid agonist combination indicated for the management of acute pain in adults.

Tyrvaya (varenicline) Nasal Spray

Date of Approval: October 15, 2021
Company: Oyster Point Pharma, Inc.
Treatment for: Dry Eye Disease

Tyrvaya (varenicline) is a nasally administered selective cholinergic agonist for the treatment of the signs and symptoms of dry eye disease.

Susvimo (ranibizumab) Injection for Intravitreal Use via Ocular Implant

Date of Approval: October 25, 2021
Company: Genentech, Inc.

Susvimo (ranibizumab) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor.

Xipere (triamcinolone acetonide) Injection

Date of Approval: October 22, 2021
Company: Clearside Biomedical, Inc.
Treatment for: Macular Edema, Uveitis

Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use is a corticosteroid indicated for the treatment of macular edema associated with uveitis.

Scemblix (asciminib) Tablets

Date of Approval: October 29, 2021
Company: Novartis
Treatment for: Chronic Myelogenous Leukemia

Scemblix (asciminib) is a tyrosine kinase inhibitor used for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

Vuity (pilocarpine hydrochloride) Ophthalmic Solution

Date of Approval: October 28, 2021
Company: AbbVie Inc.
Treatment for: Presbyopia

Vuity (pilocarpine hydrochloride) is an optimized ophthalmic solution formulation of the approved cholinergic muscarinic receptor agonist pilocarpine indicated for the treatment of presbyopia (age-related blurry near vision).

Eprontia (topiramate) Oral Solution

Date of Approval: November 5, 2021
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Epilepsy, Migraine Prevention

Eprontia (topiramate) is a ready-to-use liquid formulation of the approved anticonvulsant topiramate for use in the treatment of epilepsy and the preventive treatment of migraine.

Besremi (ropeginterferon alfa-2b-njft) Injection

Date of Approval: November 12, 2021
Company: PharmaEssentia Corporation
Treatment for: Polycythemia Vera

Besremi (ropeginterferon-alfa-2b-njft) is an interferon alfa-2b indicated for the treatment of adults with polycythemia vera.

Voxzogo (vosoritide) Lyophilized Powder for Injection

Date of Approval: November 19, 2021
Company: BioMarin Pharmaceutical Inc.
Treatment for: Achondroplasia

Voxzogo (vosoritide) is a C type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients with achondroplasia.

Fyarro (sirolimus protein-bound) Lyophilized Powder for Injectable Suspension

Date of Approval: November 22, 2021
Company: Aadi Bioscience, Inc.
Treatment for: Malignant Perivascular Epithelioid Cell Tumor (PEComa)

Fyarro (sirolimus protein-bound particles) is an inhibitor of mechanistic target of rapamycin kinase (mTOR) for the treatment of malignant perivascular epithelioid cell tumor (PEComa).

Livtencity (maribavir) Tablets

Date of Approval: November 23, 2021
Company: Takeda Pharmaceutical Company Limited
Treatment for: CMV Infection in Transplant Patients

Livtencity (maribavir) is a cytomegalovirus (CMV) pUL97 kinase inhibitor used for the treatment of post-transplant CMV infection/disease.

Cytalux (pafolacianine) Injection

Date of Approval: November 29, 2021
Company: On Target Laboratories, Inc.
Treatment for: Identification of Ovarian Cancer During Surgery

Cytalux (pafolacianine) is a fluorescent imaging agent indicated as an adjunct for the intraoperative identification of malignant lesions in patients with ovarian cancer.

PreHevbrio (hepatitis B vaccine (recombinant)) Injection

Date of Approval: November 30, 2021
Company: VBI Vaccines Inc.
Treatment for: Hepatitis B Prevention

PreHevbrio (hepatitis B vaccine (recombinant)) is a 3-antigen hepatitis B vaccine indicated for the prevention of hepatitis B virus (HBV) infection in adults.

Lyvispah (baclofen) Oral Granules

Date of Approval: November 22, 2021
Company: Saol Therapeutics, Inc.
Treatment for: Spasticity

Lyvispah (baclofen) is an oral granule formulation of the approved gamma-aminobutyric acid agonist baclofen indicated for the treatment of spasticity.

Xaciato (clindamycin phosphate) Vaginal Gel - formerly DARE-BV1

Date of Approval: December 7, 2021
Company: Daré Bioscience, Inc.
Treatment for: Bacterial Vaginosis

Xaciato (clindamycin phosphate) is a topical lincosamide antibacterial for the vaginally-administered treatment of bacterial vaginosis in female patients 12 years of age and older.

Entadfi (finasteride and tadalafil) Capsules

Date of Approval: December 9, 2021
Company: Veru Inc.
Treatment for: Benign Prostatic Hyperplasia

Entadfi (finasteride and tadalafil) is a 5α-reductase inhibitor and phosphodiesterase 5 (PDE5) inhibitor combination indicated for the treatment of urinary tract symptoms caused by benign prostatic hyperplasia (BPH).

Tarpeyo (budesonide) Delayed Release Capsules - formerly Nefecon

Date of Approval: December 15, 2021
Company: Calliditas Therapeutics AB
Treatment for: IgA Nephropathy

Tarpeyo (budesonide) is a targeted release formulation of the approved corticosteroid budesonide indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN).

Dartisla ODT (glycopyrrolate) Orally Disintegrating Tablets

Date of Approval: December 16, 2021
Company: Edenbridge Pharmaceuticals, LLC
Treatment for: Peptic Ulcer

Dartisla ODT (glycopyrrolate) is an anticholinergic indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.

Tezspire (tezepelumab-ekko) Injection

Date of Approval: December 17, 2021
Company: Amgen and AstraZeneca
Treatment for: Asthma

Tezspire (tezepelumab-ekko) is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

Vyvgart (efgartigimod alfa-fcab) Injection

Date of Approval: December 17, 2021
Company: argenx SE
Treatment for: Myasthenia Gravis

Vyvgart (efgartigimod alfa-fcab) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Yusimry (adalimumab-aqvh) Injection

Date of Approval: December 17, 2021
Company: Coherus BioSciences, Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis

Yusimry (adalimumab-aqvh) 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, and plaque psoriasis.

Apretude (cabotegravir) Extended-Release Injectable Suspension

Date of Approval: December 20, 2021
Company: ViiV Healthcare
Treatment for: Pre-Exposure Prophylaxis

Apretude (cabotegravir) is a long-acting injectable integrase strand transfer inhibitor (INSTI) indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.

Illuccix (gallium Ga 68 gozetotide) Injection Kit

Date of Approval: December 17, 2021
Company: Telix Pharmaceutical, Inc.
Treatment for: Positron Emission Tomography Imaging

Illuccix (gallium Ga 68 gozetotide) is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Leqvio (inclisiran) Injection

Date of Approval: December 22, 2021
Company: Novartis
Treatment for: High Cholesterol, Familial Heterozygous

Leqvio (inclisiran) is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA used to reduce low-density lipoprotein cholesterol.

Adbry (tralokinumab-ldrm) Injection

Date of Approval: December 27, 2021
Company: LEO Pharma Inc.
Treatment for: Atopic Dermatitis

Adbry (tralokinumab-ldrm) is an interleukin-13 antagonist used for the treatment of moderate-to-severe atopic dermatitis.

Recorlev (levoketoconazole) Capsules

Date of Approval: December 30, 2021
Company: Xeris Biopharma Holdings
Treatment for: Cushing's Syndrome

Recorlev (levoketoconazole) is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome.

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