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Status:
Possibly Marketed Outside US
First approved in 2010
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Behenic acid is a saturated fatty acid that is derived from the oil extracts of plants and used as a component of conditioning agents. Behenic acid is also a part of a novel complex of lipophilic ingredients developed for the treatment of dry skin. The properties of behenic acid were studied in comparison to others fatty acids and it was found that behenic acid does not inhibit the UDP-glucuronosyltransferase (UGT) 1A1 enzyme. The high levels of behenic acid in patients with low-grade glial tumors is an important indicator of the persistence of tissue integrity and tissue resistance. Therefore, behenic acid levels can be a prognostic factor in glial tumors.
Status:
Possibly Marketed Outside US
Source:
DENAGARD by Novartis
Source URL:
First approved in 2010
Source:
NADA140916
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Tiamulin is a diterpene antimicrobial with a pleuromutilin chemical structure similar to that of
valnemulin. The activity of tiamulin is largely confined to gram-positive micro-organisms and
mycoplasma. Tiamulin acts by inhibiting protein synthesis at the ribosomal level. In veterinary
medicine, tiamulin is used for treatment and prophylaxis of dysentery, pneumonia and
mycoplasmal infections in pigs and poultry. Tiamulin is available as a 2, 10 or 20% premix for
pigs and poultry, a 12.5% solution or 45% water soluble powder for addition to drinking water
for pigs and poultry, or a 10% injectable formulation for pigs. Tiamulin inhibits protein synthesis by targeting the 50S bacterial ribosomal subunit and binding to peptidyl transferase, the enzyme responsible for forming peptide bonds between amino acids.
Status:
Possibly Marketed Outside US
First approved in 2010
Source:
NADA140929
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Tilmicosin is a macrolide antibiotic was prepared by chemical modifications of desmycosin, and is used in veterinary. It is recommended for treatment and prevention of pneumonia in cattle, sheep and pigs, associated with Pasteurella haemolytica, P. multocida, Actinobacillus pleuropneumoniae, mycoplasma species and other microorganisms found sensitive to this compound. Tilmicosin belongs to 16-membered ring group of class macrolides. The antimicrobial mechanism seems to be the same for all of the macrolides. They interfere with protein synthesis by reversibly binding to the 50S subunit of the ribosome. They appear to bind at the donor site, thus preventing the translocation necessary to keep the peptide chain growing. The effect is essentially confined to rapidly dividing bacteria and mycoplasmas. Macrolides are regarded as being bacteriostatic but demonstrate bactericidal activity at high concentrations.
Status:
Possibly Marketed Outside US
Source:
21 CFR 347
(2010)
Source URL:
First approved in 2010
Source:
21 CFR 347
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Regrelor (INS50589) is a P2Y(12) ADP-receptor antagonist that regulates platelet function. Regrelor was found to be well-tolerated and have reversible effects. Its potential therapeutic utility in various cardiovascular settings has been studied. Initial results of canine models suggested that regrelor should be effective in protecting platelet function and reducing blood loss in human patients undergoing open-heart surgery. A phase II study testing regrelor for its safety and efficacy in reduction of postoperative bleeding and blood product transfusion was terminated due to adverse effects.
Status:
Possibly Marketed Outside US
First approved in 2010
Source:
NADA092444
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Morantel (1,4,5,6-tetrahydro-1-methyl-2-[2-(3-methyl-2-thienyl)ethenyl pyrimidine) is a
tetrahydro-pyrimidine anthelmintic, differing from the related analogue pyrantel by the presence
of a methyl group on the thiophene ring. Morantel tartrate, manufactured by Pfizer, Inc., was approved in the United
States for use in cattle in 1981, and entered the market in early 1982. Three
formulations have been approved in the United States: RUMATEL®
Medicated Premix-88; RUMATEL Cattle Wormer Bolus, and PARATECT
FLEX™ Diffuser, a sustained release bolus. It is intended to treat roundworms and tapeworms. Morantel is
administered in lactating and non lactating cattle as morantel tartrate as a slow-release bolus
(11.8 g morantel base per animal) or as a single oral dose of 6 to 7.5 mg morantel base/kg bw and
in pigs at a single dose equivalent to 7.5 mg base/kg bw. In sheep, the citrate salt is administered
at a single dose equivalent to 5 to 6 mg morantel base/kg bw. Morantel acts as a potent agonist at the acetylcholine receptors on the muscle cells of nematodes.
Activation of the acetylcholine receptors induces a prolonged, spastic paralysis of the worms and
expulsion from the host. It also been reported to block neurotransmission in vertebrates, to
possess nicotine-like properties and to mimic acetylcholine at receptors in autonomic ganglia,
adrenal medullae and respiratory tissues. Morantel and its salts are not used in human medicines.
Status:
Possibly Marketed Outside US
First approved in 2010
Source:
Fungus Fighter by Continental Manufacturing Chemist, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
AMMONIUM O-PHENYLPHENOLATE (also known as Ortho-phenylphenol, ammonium salt) is a toxic agent, which is used as a pesticide.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2010
Source:
21 CFR 358H
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 347
(2010)
Source URL:
First approved in 2010
Source:
21 CFR 347
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
The cationic surfactant, stearamidoethyl diethylamine (SD) is an emulsifier used in topical medications and cosmetics. Stearamidoethyl Diethylamine is an ingredient found in a variety of cosmetics and personal care products, primarily in shampoos and other hair care formulas, as an emulsifier, anti-static agent, and hair conditioner. It has been reported to cause allergic contact dermatitis.
Status:
Possibly Marketed Outside US
First approved in 2010
Source:
NADA092444
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Morantel (1,4,5,6-tetrahydro-1-methyl-2-[2-(3-methyl-2-thienyl)ethenyl pyrimidine) is a
tetrahydro-pyrimidine anthelmintic, differing from the related analogue pyrantel by the presence
of a methyl group on the thiophene ring. Morantel tartrate, manufactured by Pfizer, Inc., was approved in the United
States for use in cattle in 1981, and entered the market in early 1982. Three
formulations have been approved in the United States: RUMATEL®
Medicated Premix-88; RUMATEL Cattle Wormer Bolus, and PARATECT
FLEX™ Diffuser, a sustained release bolus. It is intended to treat roundworms and tapeworms. Morantel is
administered in lactating and non lactating cattle as morantel tartrate as a slow-release bolus
(11.8 g morantel base per animal) or as a single oral dose of 6 to 7.5 mg morantel base/kg bw and
in pigs at a single dose equivalent to 7.5 mg base/kg bw. In sheep, the citrate salt is administered
at a single dose equivalent to 5 to 6 mg morantel base/kg bw. Morantel acts as a potent agonist at the acetylcholine receptors on the muscle cells of nematodes.
Activation of the acetylcholine receptors induces a prolonged, spastic paralysis of the worms and
expulsion from the host. It also been reported to block neurotransmission in vertebrates, to
possess nicotine-like properties and to mimic acetylcholine at receptors in autonomic ganglia,
adrenal medullae and respiratory tissues. Morantel and its salts are not used in human medicines.
Status:
Possibly Marketed Outside US
Source:
NCT01284647: Phase 4 Interventional Completed Chronic Erosive Gastritis
(2011)
Source URL:
First approved in 2010
Source:
21 CFR 352
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Tetraprenylacetone (Geranylgeranylacetone) is an anti-peptic ulcer drug developed and approved in Japan in 1984. Tetraprenylacetone is shown to suppress H. pylori induced tissue and cell injury and inflammatory reaction, so it is expected to show beneficial effects on H. pylori-infected tissues. Tetraprenylacetone is used to treat patients suffering from peptic ulcers and gastritis. In Japan it is sold under the brand name Selbex.