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Status:
Possibly Marketed Outside US
Source:
21 CFR 350
(2020)
Source URL:
First approved in 2012
Source:
21 CFR 333E
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Benzyl acetate is used as a fragrance ingredient and occurs in different plants and fruits, e.g., jasmine, apple, tea, plum, wine grape. It possesses a sweet and pleasant aroma, owing to which, it finds applications in personal hygiene and health care products.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2012)
Source URL:
First approved in 2012
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2015)
Source URL:
First approved in 2012
Source:
M032
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2012)
Source URL:
First approved in 2012
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Status:
Possibly Marketed Outside US
First approved in 2012
Source:
Oxygen by Maniilaq Association
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Carbon monoxide (CO) is a colorless, odorless, tasteless, and nonirritating but highly toxic gas generated by both natural and manufactured processes. CO displays many physiological roles in the neuronal, cardiovascular, and immune systems, as well as in the respiratory, reproductive, gastrointestinal, and urogenital apparatus, including anti‐apoptotic, anti‐inflammatory, anti‐oxidant, anti‐proliferative, and vasodilator effects. Although many pathologies, including cancer, hematological diseases, hypertension, heart failure, inflammation, sepsis, neurodegeneration, and sleep disorders, have been linked to abnormal endogenous CO metabolism and functions, CO displays therapeutic actions. CO has demonstrated therapeutic potential against a wide range of human diseases. However, development of CO as a therapeutic agent is severely impeded, primarily due to the lack of pharmaceutically acceptable delivery forms of CO. The therapeutic use of CO is based on (i) the induction or gene transfer of HO‐1, (ii) the inhalation of gaseous CO, and (iii) the use of CO‐releasing molecules (CO‐RMs). There is a large amount of broad preclinical evidence of the benefits of CO in large and small animal models. Importantly, CO is effective both as a prophylactic and as a therapeutic in diverse models, such as malaria, organ transplantation and pulmonary hypertension. Inhaled CO and CO-RMs are in development as therapeutics; inhaled CO is being tested in Phase II clinical trials for kidney transplantation and various CO-RMs are under preclinical evaluation. The precise molecular targets for CO remain unclear with a wide range of evidence for both haem and non-haem targets. A commonality revolves around the contributions of the mitochondria and alterations in cellular bioenergetics. Inhaled CO delivery can be accomplished with an innovative delivery device. In addition strong medicinal chemistry is driving CO-RM development with efforts towards tissue specificity and the appropriate pharmacokinetic and pharmacodynamic profiling. Inhaled CO
has found wide applications in basic research
in examining CO’s physiological and pathological roles, yet its application in human has many limitations, such as difficulty in precise
dose control, lack of portability and inability for targeted delivery, among others. In order to mitigate these limitations, a family
of transition metal based CO-releasing molecules (CO-RMs) have been elegantly devised, and have shown CO-associated biological
outcomes both in vitro and in vivo.
Proterris is developing an inhaled carbon monoxide (CO) therapy for the treatment of idiopathic pulmonary fibrosis (IPF), delayed graft function (DGF), acute kidney injury and renal fibrosis.
Status:
Possibly Marketed Outside US
First approved in 2012
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Conditions:
Ethylhexyl triazone is a PABA-derivative used in sunscreens to absorb UVB radiation. It is marketed as Uvinul T 150 by BASF. Ethylhexyl triazone has an absorption maximum of 314 nm. Ethylhexyl triazone is not approved as an active ingredient in the U.S., but used in rare cases to boost efficacy of some products. Ethylhexyl triazone is approved for use up to 5% in EU and Japan. It blocks UVB and extremely stable, it is the most effective UVB filter. Only small concentrations are required to achieve high SPF value, has good affinity to keratin and completely insoluble in water, making it particularly good choice for water-resistant sunscreens. Very stable in light – ability to filter UV rays remains practically unchanged even when exposed to intense radiation.
Status:
Possibly Marketed Outside US
Source:
NADA141460
(2016)
Source URL:
First approved in 2012
Source:
NADA141336
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Tylvalosin (TVS) is a third-generation macrolide drug used for prophylaxis and treatment of mycoplasma. Tylvalosin, the active ingredient of Aivlosin
625 mg/g Water Soluble Granules (ECO
Animal Health, UK), is a modern macrolide
that has shown its effectiveness in the control
of porcine proliferative enteropathy, EP and swine dysentery. Aivlosin is indicated for the control of porcine proliferative enteropathy (PPE)
associated with Lawsonia intracellularis infection in
groups of swine in buildings experiencing an outbreak
of PPE. Tylvalosin tartrate is a macrolide antibiotic that has antibacterial activity against Gram-positive, some
Gram-negative organisms and mycoplasma. It acts by inhibiting protein synthesis in the bacteria cell.
Status:
Possibly Marketed Outside US
Source:
M020
(2024)
Source URL:
First approved in 2012
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2012)
Source URL:
First approved in 2012
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
P32 Sodium Phosphate by Anazao Health Corporation
Source URL:
First approved in 2012
Source:
Unapproved drug other
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Phosphorus P-32 (P-32) is the phosphorus isotope whose nucleus consists of 15 protons and 17 neutrons. Phosphorus P-32 is one of the most commonly used research emitters and is the one with the highest energy. Its use in molecular biology has become widespread by the use of specific high-activity nucleotides to mark DNA. Phosphorus P-32 may also be used in phosphorylation reactions. More precisely, it is used in the study of the migration of fertilizers (phosphates) in soils. In the medical field, phosphorus P-32 has been used for the treatment of polyglobulia, but this is increasingly rare. Emitted by phosphorus P-32, beta particles directly damage cellular DNA and, by ionizing intracellular water to produce several types of cytotoxic free radicals and superoxides, indirectly damage intracellular biological macromolecules, resulting in tumor cell death.