{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
Status:
Possibly Marketed Outside US
First approved in 2023
Source:
NDA216023
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Flotufolastat F 18 (POSLUMA®) is an 18F-labelled radiohybrid (rh) prostate-specific membrane antigen (PSMA)-targeted imaging agent being developed by Blue Earth Diagnostics, a subsidiary of Bracco Imaging, for prostate cancer imaging. In May 2023, flotufolastat F 18 received its first approval in the USA as a radioactive diagnostic agent for positron emission tomography (PET) of PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Flotufolastat F 18 binds to PSMA (IC50 = 4.4 nM) expressed on cells, including prostate cancer cells, and is internalized. Prostate cancer cells usually overexpress PSMA. Fluorine-18 is a beta emitting radionuclide that can be detected using positron emission tomography.
Status:
Possibly Marketed Outside US
Source:
M005
(2023)
Source URL:
First approved in 2023
Source:
M005
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
Possibly Marketed Outside US
Source:
M006
(2023)
Source URL:
First approved in 2023
Source:
M006
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
Possibly Marketed Outside US
Source:
505G(a)(3)
(2023)
Source URL:
First approved in 2023
Source:
505G(a)(3)
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
BLA125796
(2024)
Source URL:
First approved in 2023
Source:
Moderna COVID-19 Vaccine by Moderna US, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
M020
(2023)
Source URL:
First approved in 2023
Source:
M020
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Status:
Possibly Marketed Outside US
Source:
FOLLIXIL Hair and Beard Growth-Foam by Matykos Beauty LLC
(2023)
Source URL:
First approved in 2023
Source:
FOLLIXIL Hair and Beard Growth-Foam by Matykos Beauty LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
Possibly Marketed Outside US
Source:
M020
(2023)
Source URL:
First approved in 2023
Source:
M020
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
Possibly Marketed Outside US
Source:
M020
(2023)
Source URL:
First approved in 2023
Source:
M020
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
Possibly Marketed Outside US
Source:
M016
(2023)
Source URL:
First approved in 2023
Source:
M016
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
