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Status:
Possibly Marketed Outside US
Source:
M020
(2014)
Source URL:
First approved in 2013
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
M020
(2019)
Source URL:
First approved in 2013
Source:
21 CFR 358H
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
Possibly Marketed Outside US
Source:
21 CFR 348
(2013)
Source URL:
First approved in 2013
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2013
Source:
21 CFR 333C
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
Peroxiderm by GlenHaven LLC
(2016)
Source URL:
First approved in 2013
Source:
HC-PRE by BouMatic, LLC
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
First approved in 2013
Source:
GloStrips by Nomax Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Rose bengal sodium (RB) is a small molecule, halogenated xanthene being developed by Provectus Biopharmaceuticals (formerly Provectus Pharmaceuticals). It is commonly used in eye drops to stain damaged conjunctival and corneal cells and thereby identify damage to the eye. The stain is also used in the preparation of Foraminifera for microscopic analysis, allowing the distinction between forms that were alive or dead at the time of collection. A form of rose bengal is also being studied as a treatment for certain cancers and skin conditions. The cancer formulation of the drug, known as PV-10, is currently undergoing clinical trials for melanoma and breast cancer. Recently, interest in RB as a therapeutic cancer treatment has increased due to significant anti-tumor responses with direct tumor injection in human clinical trials for metastatic melanoma. In these patients, there has been the implication that RB may mount a T-cell mediated anti-tumor response and impart antigen-specific responses in distant bystander lesions.
Status:
Possibly Marketed Outside US
Source:
ANDA215304
(2013)
Source URL:
First approved in 2013
Source:
ANDA215304
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Tetraxetan (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (also known as DOTA) is used as a complexing agent. Its complexes have medical applications as contrast agents and cancer treatments. DOTA can be conjugated to monoclonal antibodies by attachment of one of the four-carboxyl groups as an amide. The modified antibody accumulates in the tumour cells, concentrating the effects of the radioactivity of 90Y. DOTA can also be linked to molecules that have an affinity for various structures. The resulting compounds are used with a number of radioisotopes in cancer therapy and diagnosis. Clivatuzumab tetraxetan is a humanized monoclonal antibody targeting a mucin antigen expressed in most pancreatic cancers, but not pancreatitis, normal pancreas or most other normal tissues. Preclinical studies in mice with human pancreatic cancer xenografts given the murine version of 90Y-clivatuzumab tetraxetan demonstrated favourable tumour responses, which could be further improved when given in combination with gemcitabine. (64)Cu-DOTA-trastuzumab PET (positron emission tomography) could be a potential noninvasive procedure for serial identification of metastatic brain lesions in patients with HER2-positive breast cancer. 90Y-DOTA-biotin may have the application of pre-targeted radioimmunotherapy for the treatment of advanced colorectal cancer in humans.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2013
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2013)
Source URL:
First approved in 2013
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
Possibly Marketed Outside US
Source:
LipoGel CR Base by Southeastern Medical Technologies
(2013)
Source URL:
First approved in 2013
Source:
LipoGel CR Base by Southeastern Medical Technologies
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets: