Drug Approvals Quarterly Update: April 2024

April 25, 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

Traditional drug approvals – 2024
Generic Name Brand Name Manufacturer Indication(s) Route of Administration Month Approved*
aprocitentan Tryvio® Idosia Difficult-to-control or resistant hypertension Oral March
budesonide Eohilia™ Takeda Inflammation caused by eosinophilic esophagitis Oral February
iloprost Aurlumyn™ Eicos Science and Actelion Severe frostbite Intravenous (IV) February
cefepime/
enmetazobactam
Exblifep® Allecra Complicated urinary tract infections IV February
letibotulinumtoxinA-wlbg Letybo® Hugel America Glabellar lines Intramuscular (IM) February
berdazimer Zelsuvmi™ Ligand Molluscum contagiosum Topical January

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

New indications for approved traditional drugs – 2024
Generic Name Brand Name Manufacturer Indication Month Approved
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
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 CV disease and obesity or overweight March
alirocumab Praluent® Regeneron Expanded pediatric indication (> 8 years of age) for heterozygous familial hypercholesterolemia March
fluticasone propionate Xhance® Optinose Chronic sinusitis including patients without polyps in the nasal cavity 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
Vaccine and immunization new approvals – 2024
Generic Name Brand Name Brand Manufacturer Indication Month Approved
None

Specialty drug approvals

Specialty drug approvals – 2024
Generic Name  Brand Name  Manufacturer  Indication(s)  Route of Administration  Month Approved 
givinostat  Duvyzat™  ITF  Duchenne muscular dystrophy (DMD)  Oral  March 
resmetirom  Rezdiffra™  Madrigal  Noncirrhotic nonalcoholic steatohepatitis (NASH)  Oral  March 
macitentan/tadalafil   Opsynvi  Johnson and Johnson  Pulmonary arterial hypertension (PAH)  Oral  March 
sotatercept-csrk  Winrevair™  Merck  PAH  SC  March 
vadadustat  Vafseo® Akebia  Anemia due to chronic kidney disease (CKD) dialysis-dependent  Oral  March 
danicopan  Voydeya™  AstraZeneca  Paroxysmal nocturnal hemoglobinuria with extravascular hemolysis  Oral  March 
New indications for approved specialty drugs -2024
Generic Name Brand Name Manufacturer New Indication(s) Month Approved
dupilumab Dupixent® Sanofi/Regeneron Expanded pediatric indication (>1 year) for eosinophilic esophagitis January
immune globulin infusion 10% (Human) with recombinant Human hyaluronidase HyQvia® Takeda Chronic inflammatory demyelinating polyneuropathy January
immune globulin infusion (Human) Gammagard Liquid® Takeda Chronic inflammatory demyelinating polyneuropathy January
omalizumab Xolair® Genentech and Novartis Reduction of allergic reactions, that may occur with an accidental exposure to one or more foods February
bictegravir/emtricitabine/tenofovir alafenamide Biktarvy® Gilead Expanded indication for HIV-1 infection with M184V/I resistance February
maralixibat Livmarli® Mirum Expanded pediatric indication for cholestatic pruritis with progressive familial intrahepatic cholestasis (PFIC) March
spesolimab-sbzo Spevigo® BI Generalized pustular psoriasis March
Factor IX, recombinant Ixinity® Medexus Expanded pediatric indication (<12 years of age) for hemophilia B March
Oncology drug approvals – 2024
Generic Name  Brand Name  Manufacturer  Indication(s)  Route of Administration  Month Approved 
tislelizumab-jsgr  Tevimbra®  BeiGene  Esophageal squamous cell carcinoma  IV  March 
New indications for approved oncology medications – 2024
Generic Name Brand Name Manufacturer New Indication Month Approved
ponatinib Iclusig® Takeda Front-line treatment of adults newly diagnosed with Philadelphia chromosome-positive (Ph+) ALL March
nivolumab Opdivo® BMS In combination with cisplatin and gemcitabine chemotherapy for first-line treatment of adults with unresectable or metastatic urothelial carcinoma (UC) March
inotuzumab ozogamicin Besponsa® Pfizer Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in pediatric patients 1 year and older 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 First-line treatment of metastatic pancreatic ductal adenocarcinoma February
osimertinib Tagrisso® AstraZeneca In combination with pemetrexed and platinum chemotherapy for first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations February
alpelisib Piqray® Novartis Pre- and perimenopausal women for use in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (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

Biosimilar approvals
Generic Name  Brand Name  Reference Product  Manufacturer  Indication(s)  Route of Administration  Month Approved 
denosumab-bbdz 

 

 

Jubbonti® Prolia®
(Interchangeable) 
Sandoz  Bone health  SC  March 
denosumab-bbdz  Wyost® Xgeva®
(Interchangeable) 
Sandoz  Bone health  SC  March 
tocilizumab-aazg  Tyenne® Actemra®  Fresenius Kabi  Autoimmune  IV/SC  March 
adalimumab-ryvk 

 

 

Simlandi® Humira®
(Interchangeable of high concentration (100 mg/mL citrate-free) 
Alvotech and Teva  Autoimmune  SC  February  
New indications for approved biosimilars – 2024
Generic Name Brand Name Manufacturer New Indication Month Approved
pegfilgrastim-bmez Ziextenzo® Sandoz Hematopoietic subsyndrome of acute radiation syndrome February
Gene/cell therapy approvals – 2024
Generic Name Brand Name Manufacturer Indication(s) Route of Administration Month Approved
atidarsagene autotemcel Lenmeldy™ Orchard Early-onset metachromatic leukodystrophy IV March
lifileucel Amtagvi™ Iovance Unresectable or metastatic melanoma IV February
New indications for approved gene/cell therapy products – 2024
Generic Name Brand Name Manufacturer Indication(s) Month Approved
lisocabtagene maraleucel Breyanzi® BMS Relapsed or refractory chronic lymphocytic or small lymphocytic lymphoma who received at least 2 lines of therapy March
exagamglogene autotemcel Casgevy® Vertex/CRISPR Transfusion-dependent beta-thalassemia January

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