FDA Approved Products

1,302 products with lifecycle intelligence, competitive pressure scores, and patent timelines.

Type:AllNDABLAANDA
Lifecycle:GrowthPeakLOE ApproachingPost-LOELaunchPre-Launch
Sort:Approval DateNameCompetitive Pressure↓
Active:Lifecycle: PeakClear all
AXUMIN
fluciclovine f-18
Peak
Blue Earth Diagnostics
INTRAVENOUS · SOLUTION
prostate cancer
2016
NDA
0/100
AYVAKIT
avapritinib
Peak
Blueprint Medicines
ORAL · TABLET
metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutationleukemia
2020
SMNDA
0/100
AZMIRO
testosterone cypionate
Peak
R-Pharm US
INTRAMUSCULAR · SOLUTION
2022
NDA
0/100
AZSTARYS
serdexmethylphenidate and dexmethylphenidate
Peak
ORAL · CAPSULE
Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of ageolder
2021
NDA
0/100
BAFIERTAM
monomethyl fumarate
Peak
ORAL · CAPSULE, DELAYED RELEASE
relapsing forms of multiple sclerosis (MS)to include clinically isolated syndrome+3
2020
NDA
0/100
BALVERSA
erdafitinib
Peak
Johnson & Johnson
ORAL · TABLET
metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed onafter at least one line of prior systemic therapy
2019
SMNDA
0/100
BAQSIMI
glucagon
Peak
R-Pharm US
NASAL · POWDER
severe hypoglycemia in adultsolder with diabetes
2019
NDA
0/100
BARHEMSYS
amisulpride
Peak
Acacia Pharma
INTRAVENOUS · SOLUTION
vomiting (PONV)either alone+1
2020
NDA
0/100
BAXDELA
delafloxacin meglumine
Peak
CorMedix
ORAL · TABLET
skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA]methicillin-susceptible [MSSA] isolates)+18
2017
NDA
0/100
BAXDELA
delafloxacin meglumine
Peak
CorMedix
INTRAVENOUS · POWDER
skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA]methicillin-susceptible [MSSA] isolates)+18
2017
NDA
0/100
BELBUCA
buprenorphine hydrochloride
Peak
BUCCAL · FILM
severepersistent pain+1
2015
NDA
0/100
BELRAPZO
bendamustine hydrochloride
Peak
Eagle Pharmaceuticals
INTRAVENOUS · SOLUTION
within six months of treatment with rituximaba rituximab-containing regimen+2
2018
NDA
0/100
BELSOMRA
suvorexant
Peak
Merck & Co.
ORAL · TABLET
insomnia characterized by difficulties with sleep onset and/or sleep maintenanceinsomnia+1
2014
NDA
0/100
BENDEKA
bendamustine hydrochloride
Peak
Eagle Pharmaceuticals
INTRAVENOUS · SOLUTION
within six months of treatment with rituximaba rituximab-containing regimen+2
2015
NDA
0/100
BEVESPI AEROSPHERE
glycopyrrolate and formoterol fumarate
Peak
AstraZeneca
INHALATION · AEROSOL, METERED
COPDasthma+1
2016
NDA
0/100
BEVYXXA
betrixaban
Peak
ORAL · CAPSULE
2017
NDA
0/100
BIJUVA
estradiol and progesterone
Peak
ORAL · CAPSULE
2018
NDA
0/100
BIKTARVY
bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
Peak
Gilead Sciences
ORAL · TABLET
2018
NDA
0/100
BINOSTO
alendronate sodium
Peak
Radius Health
ORAL · TABLET, EFFERVESCENT
osteoporosis in postmenopausal womenosteoporosis+4
2012
NDA
0/100
BLUDIGO
indigotindisulfonate sodium
Peak
INTRAVENOUS · SOLUTION
2022
NDA
0/100
BONJESTA
doxylamine succinate and pyridoxine hydrochloride
Peak
Duchesnay
ORAL · TABLET, EXTENDED RELEASE
nauseavomiting of pregnancy in women
2016
NDA
0/100
BORTEZOMIB
bortezomib
Peak
Fresenius Kabi
INTRAVENOUS · POWDER
myelomalymphoma
2017
NDA
0/100
BORTEZOMIB
bortezomib
Peak
MAIA Biotechnology
INTRAVENOUS · SOLUTION
myelomalymphoma
2022
NDA
0/100
BOSULIF
bosutinib
Peak
Pfizer
ORAL · TABLET
• adultolder with chronic phase Ph+ chronic myelogenous leukemia (CML)+4
2012
SMNDA
0/100
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