Quarterly Drug Approvals: October 2024

Generic Name	Brand Name	Manufacturer	Indication(s)	Route of Administration	Month Approved*
arimoclomol	Miplyffa	Zevra	Niemann-Pick disease type C in combination with miglustat (≥ 2 years of age)	Oral	September
lebrikizumab-lbkz	Ebglyss	Eli Lilly	Atopic dermatitis (≥ 12 years of age weighing ≥ 40 kg)	Subcutaneous (SC)	September
levacetylleucine	Aqneursa	IntraBio	Niemann-Pick disease type C (body weight ≥ 15 kg)	Oral	September
ocrelizumab/hyaluronidase-ocsq	Ocrevus Zunovo	Genentech	Relapsing & progressive multiple sclerosis	SC	September
octreotide acetate	Bynfezia Pen	Sun	(1) Acromegaly; (2) Carcinoid tumors; (3) Diarrhea associated with vasoactive intestinal peptide (VIP)-secreting tumors	SC	September
axatilimab-csfr	Niktimvo	Incyte/Syndax	Chronic graft-versus-host disease (body weight ≥ 40 kg)	Intravenous (IV)	August
nemolizumab-ilto	Nemluvio	Galderma	Prurigo nodularis	SC	August
palopegteriparatide	Yorvipath	Ascendis	Hypoparathyroidism	SC	August
seladelpar	Livdelzi	Gilead	Primary biliary cholangitis	Oral	August
deuruxolitinib	Leqselvi	Sun	Severe alopecia areata	Oral	July
donanemab-azbt	Kisunla	Eli Lilly	Early symptomatic Alzheimer's disease	IV	July
paliperidone palmitate extended-release	Erzofri	Luye	(1) Schizophrenia; (2) Schizoaffective disorder	Intramuscular (IM)	July
immune globulin intravenous, human-dira	Yimmugo	Grifols Biotest	Primary humoral immunodeficiency (≥ 2 years of age)	IV	June
crovalimab-akkz	Piasky	Genentech	Paroxysmal nocturnal hemoglobinuria (PNH) (≥ 13 years of age)	IV, SC	June
elafibranor	Iqirvo	Ipsen	Primary biliary cholangitis	Oral	June
ensifentrine	Ohtuvayre	Verona	Maintenance treatment of chronic obstructive pulmonary disease (COPD)	Oral inhalation	June
imetelstat	Rytelo	Geron	Low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia	IV	June
mavorixafor	Xolremdi	X4 Pharmaceuticals	Warts, hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome	Oral	April
danicopan	Voydeya	AstraZeneca	PNH with extravascular hemolysis	Oral	March
givinostat	Duvyzat	ITF	Duchenne muscular dystrophy (DMD)	Oral	March
macitentan/tadalafil	Opsynvi	Johnson and Johnson	Pulmonary arterial hypertension (PAH)	Oral	March
resmetirom	Rezdiffra	Madrigal	Noncirrhotic nonalcoholic steatohepatitis (NASH)	Oral	March
sotatercept-csrk	Winrevair	Merck	Pulmonary arterial hypertension (PAH)	SC	March
vadadustat	Vafseo	Akebia	Anemia due to chronic kidney disease (CKD) dialysis-dependent	Oral	March

Generic Name	Brand Name	Manufacturer	Indication(s)	Month Approved*
benralizumab	Fasenra	AstraZeneca	Eosinophilic granulomatosis with polyangiitis	September
bimekizumab-bkzx	Bimzelx	UCB	(1) Psoriatic arthritis; (2) Ankylosing spondylitis; (3) Non-radiographic axial spondyloarthritis	September
certolizumab pegol	Cimzia	UCB	Active polyarticular juvenile idiopathic arthritis (≥ 2 years of age)	September
dupilumab	Dupixent	Regeneron	Expanded pediatric indication (≥ 12 years of age) for chronic rhinosinusitis with nasal polyps	September
dupilumab	Dupixent	Regeneron	Uncontrolled chronic obstructive pulmonary disease (COPD)	September
guselkumab	Tremfya	Janssen Biotech	Moderately to severely active ulcerative colitis	September
lanreotide	no trade name	Cipla	Carcinoid syndrome	September
anacaulase-bcdb	Nexobrid	Vericel	Expanded pediatric indication (all ages) for severe thermal burns	August
iptacopan	Fabhalta	Novartis	Proteinuria reduction in primary immunoglobulin A nephropathy	August
letermovir	Prevymis	Merck	Cytomegalovirus (CMV) prophylaxis in allogeneic hematopoietic stem cell transplant (≥ 6 months of age weighing ≥ 6 kg) & high-risk kidney transplant (≥ 12 years of age weighing ≥ 40 kg) recipients	August
cerliponase alfa	Brineura	Biomarin	Expanded pediatric indication (all ages) for neuronal ceroid lipofuscinosis type 2 (CLN2)	July
fibrinogen (human)	Fibryga	Octapharma	Fibrinogen replacement in acquired fibrinogen deficiency	July
immune globulin subcutaneous, human-klhw	Xembify	Grifols	Primary humoral immunodeficiency in treatment naïve patients (≥ 2 years of age)	July
maralixibat	Livmarli	Mirum	Expanded pediatric indication (≥ 12 months of age) for progressive familial intrahepatic cholestasis (PFIC)	July
peanut (Arachis hypogaea) allergen powder-dnfp	Palforzia	Stallergenes Greer	Expanded pediatric indication (≥ 1 year of age) for allergic reactions from peanut exposure in patients with peanut allergy	July
efgartigimod alfa/ hyaluronidase-qvfc	Vyvgart Hytrulo	Argenx	Chronic inflammatory demyelinating polyneuropathy	June
risankizumab-rzaa	Skyrizi	Abbvie	Moderately to severely active ulcerative colitis	June
sarilumab	Kevzara	Sanofi	Active polyarticular juvenile idiopathic arthritis (body weight ≥ 63 kg)	June
belimumab	Benlysta	GlaxoSmithKline	Expanded pediatric indication (≥ 5 years of age) for SC administration for systemic lupus erythematosus	May
apremilast	Otezla	Amgen	Expanded pediatric indication (6 to 17 years of age, weighing ≥ 20 kg) for plaque psoriasis	April
benralizumab	Fasenra	AstraZeneca	Expanded pediatric indication (6 to 11 years of age) for severe asthma	April
vedolizumab	Entyvio	Takeda	Crohn's disease	April
factor IX, recombinant	Ixinity	Medexus	Expanded pediatric indication (<12 years of age) for hemophilia B	March
maralixibat	Livmarli	Mirum	Expanded pediatric indication (≥ 5 years of age) for cholestatic pruritus with progressive familial intrahepatic cholestasis (PFIC)	March
ravulizumab-cwvz	Ultomiris	Alexion	Neuromyelitis optica spectrum disorder (anti-aquaporin 4 antibody positive)	March
spesolimab-sbzo	Spevigo	Boeringer Ingelheim	Generalized pustular psoriasis	March
bictegravir/ emtricitabine/ tenofovir alafenamide	Biktarvy	Gilead	Expanded indication for HIV-1 infection with M184V/I resistance	February
omalizumab	Xolair	Genentech/ Novartis	Reduction of allergic reactions, that may occur with an accidental exposure to one or more foods	February
dupilumab	Dupixent	Sanofi/ Regeneron	Expanded pediatric indication (≥ 1 year of age) for eosinophilic esophagitis	January
immune globulin infusion (human)	Gammagard Liquid	Takeda	Chronic inflammatory demyelinating polyneuropathy (CIDP)	January
immune globulin infusion 10% (human)/ recombinant human hyaluronidase	HyQvia	Takeda	CIDP	January

Generic Name	Brand Name	Manufacturer	Indications(s)	Route of Administration	Month Approvd
atezolizumab/hyaluronidase-tqjs	Tecentriq Hybreza	Genentech	All intravenous (IV) indications of Tecentriq (e.g., select adults with non-small cell lung cancer [NSCLC], small cell lung cancer [SCLC], hepatocellular carcinoma, melanoma, & alveolar soft part sarcoma)	subcutaneous (SC)	September
bortezomib	no trade name	Shilpa Medicare Limited	(1) Multiple myeloma; (2) Mantle cell lymphoma	IV, SC	August
denileukin diftitox-cxdl	Lymphir	Citius	Relapsed or refractory cutaneous T-cell lymphoma	IV	August
lazertinib	Lazcluze	Janssen	First-line treatment of EGFR-mutated NSCLC in combination with amivantamab	Oral	August
vorasidenib	Voranigo	Servier	Grade 2 IDH-mutant astrocytoma or oligodendroglioma (≥ 12 years of age)	Oral	August
thiotepa	epylute	Shorla	Adenocarcinoma of the breast or ovary	IV	June
tarlatamab-dlle	Imdelltra	Amgen	Extensive stage small cell lung cancer (SCLC) with progression on or after platinum-based chemotherapy	IV	May
nogapendekin alfa inbakicept-pmln	Anktiva	ImmunityBio	Use in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS	Intravesically	April
tovorafenib	Ojemda	Day One	Relapsed or refractory (R/R) pediatric low-grade glioma with BRAF fusion or rearrangement or BRAF V600 mutation (≥ 6 months of age	Oral	April
tislelizumab-jsgr	Tevimbra	BeiGene	Esophageal squamous cell carcinoma	IV	March

Generic Name	Brand Name	Manufacturer	Indication(s)	Month Approved*
amivantamab-vmjw	Rybrevant	Janssen Biotech	Locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in combination with carboplatin and pemetrexed	September
isatuximab-irfc	Sarclisa	Sanofi-Aventis	Newly diagnosed, transplant-ineligible multiple myeloma in combination with bortezomib, lenalidomide, & dexamethasone	September
osimertinib	Tagrisso	AstraZeneca	Unresectable, stage III, EGFR-mutated NSCLC	September
pembrolizumab	Keytruda	Merck	First-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma in combination with pemetrexed and platinum chemotherapy	September
ribociclib	Kisqali	Novartis	Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II & III early breast cancer in combination with an aromatase inhibitor	September
amivantamab-vmjw	Rybrevant	Janssen	First-line treatment of EGFR-mutated NSCLC in combination with lazertinib	August
dostarlimab-gxly	Jemperli	GlaxoSmithKline	All adults with primary advanced or recurrent endometrial cancer in combination with carboplatin & paclitaxel	August
durvalumab	Imfinzi	AstraZeneca	Resectable early-stage NSCLC as neoadjuvant & adjuvant treatment before & after surgery	August
daratumumab / hyaluronidase-fihj	Darzalex Faspro	Janssen	Newly diagnosed, transplant-eligible multiple myeloma in combination with bortezomib, lenalidomide, & dexamethasone	July
ribociclib	Kisqali	Novartis	All adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with fulvestrant	July
adagrasib	Krazati	Mirati	KRAS G12C-mutated locally advanced or metastatic colorectal cancer for use in combination with cetuximab	June
blinatumomab	Blincyto	Amgen	CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy (≥ 1 month of age)	June
durvalumab	Imfinzi	AstraZeneca	Primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR)	June
epcoritamab-bysp	Epkinly	Genmab	Relapsed/refractory (R/R) follicular lymphoma following ≥ 2 prior lines of therapy	June
pembrolizumab	Keytruda	Merck	Primary advanced or recurrent endometrial carcinoma	June
repotrectinib	Augtyro	Bristol-Myers Squibb	Solid tumors that: (1) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, (2) are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and (3) have progressed following treatment or have no satisfactory alternative therapy (≥ 12 years of age)	June
selpercatinib	Retevmo	Eli Lilly	Expanded pediatric indication (2 years to < 12 years of age) for: (1) advanced or metastatic medullary thyroid cancer with a rearranged during transfection (RET) mutation, (2) advanced or metastatic thyroid cancer with a RET gene fusion, and (3) locally advanced or metastatic solid tumors with a RET gene fusion	May
alectinib	Alecensa	Genentech	Adjuvant therapy of NSCLC that is ALK+ (tumors ≥ 4 cm or node positive)	April
fam-trastuzumab deruxtecan-nxki	Enhertu	Daiichi Sankyo	Unresectable or metastatic, HER2+ solid tumors as second-line or later therapy	April
inotuzumab ozogamicin	Besponsa	Pfizer	R/R CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) (pediatric patients ≥ 1 year of age)	March
nivolumab	Opdivo	Bristol-Myers Squibb	Unresectable or metastatic urothelial carcinoma as first-line in combination with cisplatin and gemcitabine chemotherapy	March
ponatinib	Iclusig	Takeda	Newly diagnosed with Philadelphia chromosome-positive (Ph+) ALL as first-line treatment	March
zanubrutinib	Brukinsa	BeiGene	In combination with obinutuzumab for treatment of adults with R/R follicular lymphoma (FL) after ≥ 2 prior lines of systemic therapy	March
irinotecan liposome	Onivyde	Ipsen	Metastatic pancreatic ductal adenocarcinoma as first-line treatment	February
osimertinib	Tagrisso	AstraZeneca	Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, for use in combination with pemetrexed and platinum chemotherapy (first-line)	February
alpelisib	Piqray	Novartis	Pre- and perimenopausal women for use in combination with fulvestrant for the treatment of adults with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer	January
pembrolizumab	Keytruda	Merck	In combination with chemoradiotherapy for newly diagnosed patients with advanced cervical cancer	January
erdafitinib	Balversa	Janssen	Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations who progressed on or after ≥ 1 line of systemic therapy	January

Generic Name	Brand Name	Manufacturer	Indication(s)	Route of Administration	Month Approved*
xanomeline/trospium chloride	Cobenfy	Bristol Myers Squibb	Schizophrenia	Oral	September
carbidopa/levodopa extended-release	Crexont	Amneal	Parkinson's disease	Oral	August
epinephrine nasal spray	Neffy	ARS	Allergic reactions including anaphylaxis (patients weighing ≥ 30 kg)	Intranasal	August
nalmefene injection	Zurnai	Purdue	Opioid overdose (≥ 12 years of age)	Intramuscular (IM), subcutaneous (SC)	August
benzgalantamine delayed-release	Zunveyl	Alpha Cognition	Alzheimer's disease	Oral	July
norethindrone acetate/ethinyl estradiol orally disintegrating tablets	Femlyv	Millicent	Pregnancy prevention (females of reproductive potential)	Oral	July
sitagliptin/metformin hydrochloride extended-release	Zituvimet XR	Zydus	Type 2 diabetes mellitus (T2DM)	Oral	July
terazosin oral solution	Tezruly	Ani	(1) Benign prostatic hyperplasia; (2) Hypertension	Oral	July
sofpironium	Sofdra	Botanix	Primary axillary hyperhidrosis (≥ 9 years of age)	Topical	June
tadalafil	Chewtadzy	Ani	(1) Erectile dysfunction (ED); (2) Signs and symptoms of benign prostatic hyperplasia (BPH); and (3) ED and the signs and symptoms of BPH (ED/BPH)	Oral	June
vigabatrin	Vigafyde	Pyros	Infantile spasms for whom the potential benefits outweigh the potential risk of vision loss (patients 1 month to 2 years of age) (monotherapy)	Oral	June
clonidine	Onyda XR	Tris	Attention deficit hyperactivity disorder (ADHD) (pediatric patients ≥ 6 years of age)	Oral	May
mycophenolate mofetil oral suspension	Myhibbin	Azurity	Organ rejection prophylaxis (≥ 3 months of age)	Oral	May
ceftobiprole medocaril	Zevtera	Basilea	(1) Staphylococcus aureus bacteremia (adults); (2) Acute bacterial skin and skin structure infections (adults); (3) Community-acquired bacterial pneumonia (ages ≥ 3 months)	Intravenous (IV)	April
diazepam buccal film	Libervant	Aquestive	Acute treatment of intermittent, stereotypic episodes of frequent seizure activity distinct from a patient’s usual seizure pattern (2 to 5 years of age)	Oral transmucosal	April
naloxone (high-dose)	Rezenopy	Summit	Opioid overdose	Intranasal	April
pivmecillinam	Pivya	Utility Therapeutics	Uncomplicated urinary tract infections (UTI) in adult females	Oral	April
valbenazine	Ingrezza Sprinkle	Neurocrine Biosciences	Huntington’s disease-associated tardive dyskinesia and chorea	Oral	April
aprocitentan	Tryvio	Idosia	Difficult-to-control or resistant hypertension	Oral	March
risperidone extended-release injection	Risvan	Laboratorios Farmacéuticos Rovi	Schizophrenia	IM	March
budesonide	Eohilia	Takeda	Inflammation caused by eosinophilic esophagitis	Oral	February
cefepime/enmetazobactam	Exblifep	Allecra	Complicated UTI	IV	February
iloprost	Aurlumyn	Eicos Science/Actelion	Severe frostbite	IV	February
letibotulinumtoxinA-wlbg	Letybo	Hugel America	Glabellar lines	IM	February
berdazimer	Zelsuvmi	Ligand	Molluscum contagiosum	Topical	January

Generic Name	Brand Name	Manufacturer	Indication(s)	Month Approved*
roflumilast cream 0.15%	Zoryve	Arcutis	Expanded pediatric indication (≥ 6 years of age) for atopic dermatitis	July
sucroferric oxyhydroxide	Velphoro	Fresenius	Expanded pediatric indication (≥ 9 years of age) for hyperphosphatemia in chronic kidney disease (CKD) on dialysis	July
vonoprazan	Voquezna	Phathom	Heartburn associated with non-erosive gastroesophageal reflux disease (GERD)	July
dapagliflozin	Farxiga	AstraZeneca	Expanded pediatric indication (≥ 10 years of age) as adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus (T2DM)	June
dapagliflozin/metformin	Xigduo XR	AstraZeneca	Expanded pediatric indication (≥ 10 years of age) as adjunct to diet and exercise to improve glycemic control in patients with T2DM	June
lacosamide	Motpoly XR	Aucta	Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (adults and pediatric patients weighing at ≥ 50 kg)	June
pitolisant	Wakix	Harmony	Excessive daytime sleepiness in patients with narcolepsy (≥ 6 years of age)	June
dolutegravir/lamivudine	Dovato	Viiv	Expanded pediatric indication (≥ 12 years of age, weighing ≥ 25 kg) for treatment of human immunodeficiency-1 (HIV-1) infection	April
iloperidone	Fanapt	Vanda	Acute treatment of manic or mixed episodes in adults with bipolar I disorder	April
alirocumab	Praluent	Regeneron	Expanded pediatric indication (≥ 8 years of age) for heterozygous familial hypercholesterolemia	March
baloxavir marboxil tablet and granules for oral suspension	Xofluza	Genentech	Expanded pediatric indication (5 to < 12 years of age) for influenza	March
bempedoic acid	Nexletol	Esperion	Reduce the risk of myocardial infarction (MI) and coronary revascularization in adults unable to take recommended statin therapy, at high risk or with established cardiovascular (CV) disease (CVD)	March
bempedoic acid/ezetimibe	Nexlizet	Esperion	Reduce the risk of MI and coronary revascularization in adults unable to take recommended statin therapy, at high risk or with established CVD	March
fluticasone propionate	Xhance	Optinose	Chronic sinusitis including patients without polyps in the nasal cavity	March
rilpivirine	Edurant and Edurant PED	Janssen	Expanded pediatric indication (2 to 12 years of age, weighing ≥ 25 kg to < 35 kg, treatment-naïve with HIV-1 RNA ≤ 100,000 copies/mL) for HIV-1 infection	March
semaglutide	Wegovy	Novo Nordisk	Higher dose than used in diabetes approved for risk reduction of major adverse events (CV death, non-fatal MI, or non-fatal stroke) in adults with established CVD and obesity or overweight	March
tenofovir alafenamide	Vemlidy	Gilead	Expanded pediatric indication (6 years to < 12 years of age, weighing ≥ 25 kg) for chronic hepatitis B virus infection	March
remdesivir	Veklury	Gilead	Expanded pediatric indication (from birth) for COVID-19	February
ceftazidime/avibactam	Avycaz	AbbVie	Expanded pediatric indication (birth to < 3 months of age) for certain bacterial infections	January

Generic Name	Brand Name	Manufacturer	Indication(s)	Route of Administration	Month Approved*
smallpox and mpox (vaccinia) vaccine, live	ACAM2000	Emergent	Mpox disease prevention in high-risk patients	Percutaneous	August
pneumococcal 21-valent conjugate vaccine	Capvaxive	Merck	Active immunization for the prevention of invasive disease caused by certain Streptococcus pneumoniae (ages ≥ 18 years); active immunization for the prevention of pneumonia caused by S. pneumoniae certain serotypes (ages ≥ 18 years)	Intramuscular (IM)	June
Respiratory syncytial virus (RSV) vaccine	mRESVIA	Moderna	Prevention of RSV-related lower respiratory tract disease (LRTD) in individuals ≥ 60 years of age	IM	May

Generic Name	Brand Name	Manufacturer	Indication(s)	Route of Administration	Month Approved*
RSV vaccine, adjuvanted	Arexvy	GlaxoSmithKline	Expanded indication (50 to 59 years of age) for the prevention of RSV-associated LRTD who are at an increased risk for the condition	IM	June

Generic Name	Brand Name	Reference Product	Manufacturer	Indication(s)	Route of Administration	Month Approved*
ustekinumab-aauz	Otulfi	Stelara	Fresenius Kabi	Autoimmune disorders	Intravenous (IV), Subcutaneous (SC)	September
aflibercept-abzv	Enzeevu (provisionally interchangeable)	Eylea	Sandoz	Macular & retinal disorders	Intravitreal	August
aflibercept-ayyh	Pavblu (provisionally interchangeable)	Eylea	Amgen	Macular & retinal disorders	Intravitreal	August
eculizumab-aagh	Epysqli	Soliris	Samsung Bioepis	(1) Paroxysmal nocturnal hemoglobinuria (PNH); (2) Atypical hemolytic uremic syndrome	IV	July
aflibercept-mrbb	Ahzantive	Eylea	Formycon	Macular & retinal disorders	Intravitreal	June
filgrastim-txid	Nypozi	Neupogen	Tanvex	Neutropenia; Stem cell mobilization	IV, SC	June
ustekinumab-ttwe	Pyzchiva (provisionally interchangeable)	Stelara	Sandoz/ Samsung Bioepis	Autoimmune disorders	IV, SC	June
aflibercept-jbvf	Yesafili	Eylea	Biocon	Macular & retinal disorders	Intravitreal	May
aflibercept-yszy	Opuviz	Eylea	Samsung Bioepis/ Biogen	Macular & retinal disorders	Intravitreal	May
eculizumab-aeeb	Bkemv (interchangeable)	Soliris	Amgen	PNH; Atypical hemolytic uremic syndrome	IV	May
trastuzumab-strf	Hercessi	Herceptin	Accord	Breast cancer (HER2+); Gastric cancer (HER2+)	IV	April
ustekinumab-aekn	Selarsdi	Stelara	Alvotech/ Teva	Plaque psoriasis (≥ 6 years of age); Psoriatic arthritis (≥ 6 years of age)	SC	April
denosumab-bbdz	Jubbonti (interchangeable)	Prolia	Sandoz	Bone health	SC	March
denosumab-bbdz	Wyost	Xgeva	Sandoz	Bone health	SC	March
tocilizumab-aazg	Tyenne	Actemra	Fresenius Kabi	Autoimmune disorders	IV, SC	March
adalimumab-ryvk	Simlandi (interchangeable of high concentration [100 mg/mL citrate-free])	Humira	Alvotech/ Teva	Autoimmune disorders	SC	February

Generic Name	Brand Name	Manufacturer	Indication(s)	Month Approved*
tocilizumab-bavi	Tofidence	Biogen	(1) Giant cell arteritis; (2) Hospitalized adults with COVID-19	July
adalimumab-adbm (100 mg/mL) (new formulation)	Cyltezo	Boehringer Ingelheim	Autoimmune disorders	April
pegfilgrastim-bmez	Ziextenzo	Sandoz	Hematopoietic subsyndrome of acute radiation syndrome	February

Generic Name	Brand Name	Manufacturer	Indication(s)	Route of Administration	Month Approved*
afamitresgene autoleucel	Tecelra	Adaptimmune	Unresectable or metastatic synovial sarcoma	IV	August
fidanacogene elaparvovec-dzkt	Beqvez	Pfizer	Hemophilia B without AAVRh74var capsid neutralizing antibodies	IV	April
atidarsagene autotemcel	Lenmeldy	Orchard	Early-onset metachromatic leukodystrophy	IV	March
lifileucel	Amtagvi	Iovance	Unresectable or metastatic melanoma	IV	February

Generic Name	Brand Name	Manufacturer	Indication(s)	Month Approved*
delandistrogene moxeparvovec-rokl	Elevidys	Sarepta	Expanded indication to include ambulatory patients ≥ 4 years of age (full approval) and non-ambulatory patients ≥ 4 years of age (Accelerated Approval) with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene	June
lisocabtagene maraleucel	Breyanzi	Bristol-Myer Squibb	Relapsed/refractory (R/R) mantle cell lymphoma (MCL) following ≥ 2 prior lines of systemic therapy; R/R follicular lymphoma following ≥ 2 prior lines of systemic therapy	May
ciltacabtagene autotemcel	Carvykti	Janssen	R/R multiple myeloma following ≥ 1 prior line of therapy	April
idecabtagene vicleucel	Abecma	Bristol-Myer Squibb	R/R multiple myeloma following ≥ 2 prior lines of therapy	April
lisocabtagene maraleucel	Breyanzi	Bristol-Myer Squibb	R/R chronic lymphocytic or small lymphocytic lymphoma following ≥ 2 prior lines of therapy	March
exagamglogene autotemcel	Casgevy	Vertex/ CRISPR	Transfusion-dependent beta-thalassemia	January
All brand names are property of their respective owners.

About us

Corporate social responsibility

Solutions overview

Modern technology

Drug access

Clinical solutions

Condition management

Specialty drug management

Government solutions

Single-state programs

Read

Watch

Listen

Home Delivery

Specialty Pharmacy

Navigate to

Back

Back

Back

Back

Specialty drug approvals

Traditional drug approvals

Biosimilars and gene/cell therapy drug approvals

Login Portals

Compliance / Legal

Company