FDA Approved Products

190 products with lifecycle intelligence, competitive pressure scores, and patent timelines.

Type:AllNDABLAANDA
Lifecycle:GrowthPeakLOE ApproachingPost-LOELaunchPre-Launch
Sort:Approval DateNameCompetitive Pressure↓
Active:Lifecycle: GrowthClear all
EDURANT PED
rilpivirine hydrochloride
Growth
Johnson & Johnson
ORAL · TABLET, FOR SUSPENSION
human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 2 years of ageolder+15
2024
NDA
0/100
EMBLAVEO
aztreonam and avibactam
Growth
AbbVie
INTRAVENOUS · POWDER
olderno alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli+5
2025
NDA
0/100
EMROSI
minocycline hydrochloride extended-release
Growth
Journey Medical
ORAL · CAPSULE, EXTENDED RELEASE
inflammatory lesions (papulespustules) of rosacea in adults+3
2024
NDA
0/100
ENSACOVE
ensartinib
Growth
Xcovery
ORAL · CAPSULE
metastatic non-small cell lung cancer (NSCLC)lung cancer+1
2024
SMNDA
0/100
ENTRESTO SPRINKLE
sacubitril and valsartan
Growth
Novartis
ORAL · CAPSULE, PELLETS
symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one yearolder+4
2024
SMNDA
0/100
EOHILIA
budesonide
Growth
Takeda
ORAL · SUSPENSION
2024
NDA
0/100
EPINEPHRINE
epinephrine
Growth
Fresenius Kabi
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS · SOLUTION
2025
NDA
0/100
ERZOFRI
paliperidone palmitate
Growth
INTRAMUSCULAR · SUSPENSION, EXTENDED RELEASE
Schizophrenia
2024
NDA
0/100
EVRYSDI
risdiplam
Growth
Roche
ORAL · TABLET
spinal muscular atrophy (SMA) in pediatric
2025
NDA
0/100
EXBLIFEP
cefepime hydrochloride; enmetazobactam
Growth
INTRAVENOUS · POWDER
the treatment of pneumonia (moderate to severe) caused by susceptible strains of Streptococcus pneumoniaeincluding cases associated with concurrent bacteremia+16
2024
NDA
0/100
FABHALTA
iptacopan
Growth
Novartis
ORAL · CAPSULE
to reduce proteinuriaproteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression+1
2023
NDA
0/100
FEMLYV
norethindrone acetate/ethinyl estradiol
Growth
Millicent Pharma
ORAL · TABLET, ORALLY DISINTEGRATING
pregnancy () Limitations of Use The efficacy in females of reproductive potential with a body mass index of more than 35 kg/m has not been evaluated (
2024
NDA
0/100
FILSUVEZ
birch triterpenes
Growth
Chiesi
TOPICAL · GEL
wounds associated with dystrophicjunctional epidermolysis bullosa in adult+1
2023
NDA
0/100
FLYRCADO
flurpiridaz f-18
Growth
INTRAVENOUS · SOLUTION
2024
NDA
0/100
FOCINVEZ
fosaprepitant dimeglumine
Growth
INTRAVENOUS · SOLUTION
older for the prevention of: acutedelayed nausea+5
2023
NDA
0/100
FRINDOVYX
cyclophosphamide
Growth
Viatris (2)
INTRAVENOUS · SOLUTION
lymphocytic lymphomamixed-cell type lymphoma+2
2023
NDA
0/100
FRUZAQLA
fruquintinib
Growth
Takeda
ORAL · CAPSULE
oxaliplatin‑irinotecan‑based chemotherapy+5
2023
SMNDA
0/100
GOMEKLI
mirdametinib
Growth
SpringWorks Therapeutics
ORAL · CAPSULE
2025
SMNDA
0/100
GOMEKLI
mirdametinib
Growth
SpringWorks Therapeutics
ORAL · TABLET, FOR SUSPENSION
2025
SMNDA
0/100
GOZELLIX
gozetotide
Growth
Innovation Pharmaceuticals
INTRAVENOUS · POWDER
prostate cancer
2025
PeptideNDA
0/100
HEPZATO
melphalan hydrochloride injection, powder, lyophilized, for solution
Growth
Delcath
INTRA-ARTERIAL · POWDER
2023
NDA
0/100
IMKELDI
imatinib oral
Growth
ORAL · SOLUTION
2024
NDA
0/100
INGREZZA SPRINKLE
valbenazine
Growth
ORAL · CAPSULE
2024
NDA
0/100
INZIRQO
hydrochlorothiazide
Growth
ORAL · FOR SUSPENSION
hypertension in adultto lower blood pressure+1
2025
NDA
0/100
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