Quarterly Drug Approvals: April 2025

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
diazoxide choline	Vykat XR	Soleno	Hyperphagia in Prader-Willi syndrome (≥ 4 years of age)	Oral	March
fitusiran	Qfitlia	Sanofi	Bleed prophylaxis in hemophilia A or B with or without inhibitors (≥ 12 years of age)	SC	March
tesamorelin F8 formulation	Egrifta WR	Theratechnologies	HIV lipodystrophy	SC	March
apomorphine HCl	Onapgo	Supernus	Advanced Parkinson's disease	SC (continuous infusion)	February
chenodiol	Ctexli	Mirum	Cerebrotendinous xanthomatosis	Oral	February

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
fluocinolone acetonide	Iluvien	Ani	Chronic non-infectious uveitis affecting the posterior segment of the eye	Intravitreal	March
furosemide	Furoscix	scPharmaceuticals	Edema in patients with CKD	SC (continuous infusion)	March
guselkumab	Tremfya	Janssen	Crohn's disease	IV, SC	March
iptacopan	Fabhalta	Novartis	Complement 3 glomerulopathy	Oral	March
nedosiran	Rivfloza	Novo Nordisk	Expanded indication (≥ 2 years of age) for primary hyperoxaluria type 1	SC	March
vutrisiran	Amvuttra	Alnylam	Transthyretin amyloid cardiomyopathy (ATTR-CM)	SC	March
eculizumab	Soliris	Alexion	Expanded indication (≥ 6 years of age) for generalized myasthenia gravis	IV	February
ranibizumab	Susvimo	Genentech	Diabetic macular edema	Intravitreal	February
esketamine	Spravato	Janssen	Monotherapy for treatment-resistant depression	Intranasal	January
mirikizumab-mrkz	Omvoh	Eli Lilly	Crohn's disease	IV, SC	January

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
mirdametinib	Gomekli	SpringWorks	Neurofibromatosis type 1-associated plexiform neurofibromas (≥ 2 years of age)	Oral	February
vimseltinib	Romvimza	Deciphera	Symptomatic tenosynovial giant cell tumor	Oral	February
datopotamab deruxtecan-dlnk	Datroway	Daiichi Sankyo	Unresectable or metastatic HR+, HER2- (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer	IV	January
treosulfan	Grafapex	Medexus	Preparative regimen for allogeneic HSCT in combination with fludarabine for patients with AML or MDS (≥ 1 year of age)	IV	January
nilotinib d-tartrate	no trade name	Cipla	Newly diagnosed Ph+ CML in chronic phase (CP); (2) CP and accelerated phase Ph+ CML resistant to imatinib	Oral	February

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
cabozantinib	Cabometyx	Exelixis	Pancreatic and extra-pancreatic neuroendocrine tumors (≥ 12 years of age)	Oral	March
durvalumab	Imfinzi	AstraZeneca	Neoadjuvant and adjuvant treatment for muscle invasive bladder cancer	IV	March
tislelizumab-jsgr	Tevimbra	BeiGene	First line for advanced esophageal squamous cell carcinoma in combination with platinum-containing chemotherapy	IV	March
brentuximab vedotin	Adcetris	Seagen	R/R large B-cell lymphoma in combination with lenalidomide and rituximab	IV	February
acalabrutinib	Calquence	AstraZeneca	Untreated mantle cell lymphoma in combination with bendamustine and rituximab	Oral	January
fam-trastuzumab deruxtecan-nxki	Enhertu	Daiichi Sankyo	Unresectable or metastatic HR+, HER2- (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer	IV	January
panitumumab	Vectibix	Amgen	KRAS G12C-mutated metastatic colorectal cancer in combination with sotorasib	IV	January
sotorasib	Lumakras	Amgen	KRAS G12C-mutated metastatic colorectal cancer in combination with panitumumab	Oral	January

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
chlorthalidone	Hemiclor	PRM	HTN	Oral	March
gepotidacin	Blujepa	GSK	Uncomplicated UTI (females ≥ 12 years of age)	Oral	March
losartan oral suspension	Arbli	Scienture	(1) HTN (> 6 years of age); (2) Risk reduction in patients with HTN and LVH; (3) Diabetic nephropathy	Oral	March
aztreonam / avibactam	Emblaveo	Abbvie	Complicated intra-abdominal infections in combination with metronidazole	IV	February
copper intrauterine system	Miudella	Sebela Women's Health	Pregnancy prevention for up to 3 years	Intrauterine	February
hydrochlorothiazide oral suspension	Inzirqo	Ani	Adults and pediatric patients with (1) HTN; (2) Edema associated with CHF, hepatic cirrhosis and renal disease	Oral	January
meloxicam / rizatriptan	Symbravo	Axsome	Acute treatment of migraine	Oral	January
sitagliptin oral solution	Brynovin	Azurity	T2DM	Oral	January
suzetrigine	Journavx	Vertex	Moderate to severe acute pain	Oral	January

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
darunavir / cobicistat	Prezcobix	Janssen	Expanded indication (≥ 25 kg to < 40 kg) for HIV-1 infection	Oral	March
epinephrine nasal spray	Neffy	ARS	Expanded indication (≥ 4 years of age weighing ≥ 15 kg) for type I allergic reactions	Intranasal	March
glucagon nasal powder	Baqsimi	Amphastar	Expanded indication (1 to 3 years of age) for severe hypoglycemia	Intranasal	March
emtricitabine / rilpivirine / tenofovir alafenamide	Odefsey	Gilead	Expanded indication (≥ 25 kg to < 35 kg) for HIV-1 infection	Oral	February
house dust mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) allergen extract	Odactra	ALK-Abello	Expanded indication (5 to 11 years of age) for house dust mite-induced allergic rhinitis	Oral	February
moxidectin	no trade name	Medicines Development for Global Health	Expanded indication (4 to < 12 years of age) for onchocerciasis	Oral	February
semaglutide	Ozempic	Novo Nordisk	Reduce risk of worsening kidney disease and CV death in patients with T2DM and CKD	SC	January

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
smallpox and mpox vaccine, live, non-replicating, freeze-dried formulation	Jynneos	Bavarian Nordic	Prevention of smallpox and mpox disease	IM	March
chikungunya vaccine, recombinant	Vimkunya	Bavarian Nordic	Prevention of chikungunya virus disease (≥ 12 years of age)	IM	February
meningococcal groups A, B, C, W and Y vaccine	Penmenvy	GSK	Prevention of disease caused by Neisseria meningitidis serogroups A, B, C, W and Y (10 through 25 years of age)	IM	February

None

Generic name	Brand name	Reference product	Manufacturer	Indication(s)	Route of administration	Month approved*
denosumab-bnht	Bomyntra	Xgeva	Fresenius Kabi	Bone health	SC	March
denosumab-bnht	Conexxence	Prolia	Fresenius Kabi	Bone health	SC	March
omalizumab-igec	Omlyclo (interchangeable)	Xolair	Celltrion	(1) Asthma; (2) Chronic rhinosinusitis with nasal polyps; (3) IgE-mediated food allergies; (4) Chronic spontaneous urticaria	SC	March
denosumab-bmwo	Osenvelt	Xgeva	Celltrion	Bone health	SC	February
denosumab-bmwo	Stoboclo	Prolia	Celltrion	Bone health	SC	February
denosumab-dssb	Ospomyv	Prolia	Samsung Bioepis	Bone health	SC	February
denosumab-dssb	Xbryk	Xgeva	Samsung Bioepis	Bone health	SC	February
insulin aspart-szjj	Merilog, Merilog SoloStar	Novolog	Sanofi-Aventis	Diabetes mellitus	SC	February
tocilizumab-anoh	Avtozma	Actemra	Celltrion	Autoimmune disorders and COVID-19	IV, SC	January

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
tocilizumab-aazg	Tyenne	Fresenius Kabi	(1) Hospitalized adults with COVID-19; (2) CAR T cell-induced CRS (≥ 2 years of age)	IV	February

Generic name	Brand name	Manufacturer	Indication(s)	Route of administration	Month approved*
revakinagene taroretcel-lwey	Encelto	Neurotech	Macular telangiectasia type 2	Intravitreal	March

None

AAVRh74var adeno-associated virus serotype Rh74var
AchR acetylcholine receptor
ADHD attention deficit hyperactivity disorder
ALK anaplastic lymphoma kinase
ALK+ anaplastic lymphoma kinase-positive
ALL acute lymphoblastic leukemia
AML acute myeloid leukemia
AQP4 anti-aquaporin-4
BPH benign prostatic hyperplasia
BRAF v-raf murine sarcoma viral oncogene homolog B1
CAR chimeric antigen receptor
CD19+ cluster of differentiate 19-positive
CD22+ cluster of differentiate 22-positive
CFTR cystic fibrosis transmembrane conductance regulator
CIDP chronic inflammatory demyelinating polyneuropathy
CKD chronic kidney disease
CML chronic myeloid leukemia
COPD chronic obstructive pulmonary disease
COVID-19 coronavirus disease 2019
CRS cytokine release syndrome
CV cardiovascular
CVD cardiovascular disease
DMD Duchenne muscular dystrophy
EGFR epidermal growth factor receptor
ER extended release
FGFR3 fibroblast growth factor receptor 3
GERD gastroesophageal reflux disease
GVHD graft versus host disease
HCI hydrochloride
HER2 human epidermal growth factor receptor 2
HER2+ human epidermal growth factor receptor 2-positive
HER2- human epidermal growth factor receptor 2-negative
HF heart failure
HIV-1 human immunodeficiency virus type-1
HR hormone receptor
HR+ hormone receptor-positive
HSCT hematopoietic stem cell transplant
HTN hypertension
Ig immunoglobulin
IDH isocitrate dehydrogenase
IHC immunohistochemistry
IM intramuscular
ISH in situ hybridization
IV intravenous
KMT2A lysine methyltransferase 2A gene
KRAS Kirsten rat sarcoma virus
LEPR leptin receptor
LRTD lower respiratory tract disease
LVH left ventricular hypertrophy
MDS myelodysplastic syndrome
mFOLFOX6 fluorouracil, leucovorin, oxaliplatin
MI myocardial infarction
NRG1+ neuregulin 1-positive
NSCLC non-small cell lung cancer
NTRK neurotrophic tyrosine receptor kinase
ODT orally disintegrating tablet
PCSK1 proprotein convertase subtilisin/kexin type 1
PD-L1+ programmed death-ligand 1-positive
Ph+ Philadelphia chromosome-positive
Ph- Philadelphia chromosome-negative
PIK3CA phosphatidylinositol-3-kinase catalytic subunit alpha
POMC pro-opiomelanocortin
R/R relapsed or refractory
RET rearranged during transfection
RNA ribonucleic acid
RSV respiratory syncytial virus
SC subcutaneous
SCLC small cell lung cancer
T2DM type 2 diabetes mellitus
UTI urinary tract infection
VTE venous thromboembolism
XR extended release

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