Drug Approvals Quarterly Update: July 2024

This wrap-up provides a review of newly approved drugs, recent drug launches, new indications and news of note on drugs in the approval process.

Traditional drug approvals

Generic Name	Brand Name	Manufacturer	Indication(s)	Route of Administration	Month Approved*
sofpironium	Sofdra™	Botanix	Primary axillary hyperhidrosis in patients ≥ 9 years of age	Topical	June
tadalafil	Chewtadzy™	Ani	(1) Erectile dysfunction (ED); (2) the 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 in patients 1 month to 2 years of age (monotherapy)	Oral	June
clonidine	Onyda™ XR	Tris	Attention deficit hyperactivity disorder (ADHD) in pediatric patients ≥ 6 years of age	Oral	May
mycophenolate mofetil oral suspension	Myhibbin™	Azurity	Organ rejection prophylaxis in patients ≥ 3 months of age	Oral	May
ceftobiprole medocaril	Zevtera®	Basilea	Staphylococcus aureus bacteremia (adults); Acute bacterial skin and skin structure infections (adults); 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 in patients 2 to 5 years of age	Oral transmucosal	April
naloxone (high-dose)	Rezenopy™	Summit	Opioid overdose	Intranasal	April
pivmecillinam	Pivya™	Utility Therapeutics	Uncomplicated 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 (adults)	Intramuscular (IM)	March
budesonide	Eohilia™	Takeda	Inflammation caused by eosinophilic esophagitis	Oral	February
cefepime/enmetazobactam	Exblifep®	Allecra	Complicated urinary tract infections (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*
dapagliflozin	Farxiga®	AstraZeneca	Expanded pediatric indication (ages ≥ 10 years) 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 (ages ≥ 10 years) 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 in adults and in pediatric patients weighing at ≥ 50 kg	June
pitolisant	Wakix®	Harmony	Excessive daytime sleepiness in patients with narcolepsy in patients ≥ 6 years of age	June
dolutegravir/lamivudine	Dovato	Viiv	Expanded pediatric indication (ages ≥ 12 years, 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	Xofluza®	Genentech	Expanded pediatric indication (5 to < 12 years of age) for the tablet and granules for oral suspension formulations for influenza	March
bempedoic acid	Nexletol®	Esperion	Reduce the risk of myocardial infarction and coronary revascularization in adults unable to take recommended statin therapy, at high risk or with established cardiovascular disease (CVD)	March
bempedoic acid/ezetimibe	Nexlizet®	Esperion	Reduce the risk of myocardial infarction 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 cardiovascular (CV) events (CV death, non-fatal myocardial infarction [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*
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)	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 (age 50 to 59 years) for the prevention of RSV-associated LRTD who are at an increased risk for the condition	IM	June

Specialty drug approvals

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

Generic Name	Brand Name	Manufacturer	Indication(s)	Month Approved*
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 in patients weighing ≥ 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 (adults)	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	January
immune globulin infusion 10% (human)/ recombinant human hyaluronidase	HyQvia®	Takeda	Chronic inflammatory demyelinating polyneuropathy	January

Generic Name	Brand Name	Manufacturer	Indication(s)	Route of Administration	Month Approved*
thiotepa	Tepylute	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 in patients ≥ 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*
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 in patients ≥ 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	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 in patients ≥ 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	Non-small cell lung cancer (NSCLC) (ALK+, tumors ≥ 4 cm or node positive, adjuvant therapy)	April
fam-trastuzumab deruxtecan-nxki	Enhertu®	Daiichi Sankyo	Unresectable or metastatic, HER2+ solid tumors (≥ 2nd-line)	April
inotuzumab ozogamicin	Besponsa®	Pfizer	Relpased or refractory CD22-positive B-cell precursor ALL in pediatric patients 1 year and older	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 relapsed or refractory follicular lymphoma (r/r FL) after at least two 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 as first-line therapy	February
alpelisib	Piqray®	Novartis	Pre- and perimenopausal women for use in combination with fulvestrant for the treatment of adults with hormone receptor (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 at least one line of systemic therapy	January

Biosimilars and gene/cell therapy drug approvals

Generic Name	Brand Name	Reference Product	Manufacturer	Indication(s)	Route of Administration	Month Approved*
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®	Stelara® (provisionally interchangeable)	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™	Soliris® (interchangeable)	Amgen	Paroxysmal nocturnal hemoglobinuria; 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 (ages ≥ 6 years); Psoriatic arthritis (ages ≥ 6 years)	SC	April
denosumab-bbdz	Jubbonti®	Prolia® (interchangeable)	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®	Humira® (interchangeable of high concentration [100 mg/mL citrate-free])	Alvotech/ Teva	Autoimmune disorders	SC	February

Generic Name	Brand Name	Manufacturer	Indication(s)	Month Approved*
adalimumab-adbm (100 mg/mL)	Cyltezo®	Boehringer Ingelheim	Autoimmune disorders (new formulation)	April
pegfilgrastim-bmez	Ziextenzo®	Sandoz	Hematopoietic subsyndrome of acute radiation syndrome	February

Generic Name	Brand Name	Manufacturer	Indication(s)	Route of Administration	Month Approved*
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	R/R mantle cell lymphoma (MCL) following ≥ 2 prior lines of systemic therapy; R/Ry 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

Disclaimer

*Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer.

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