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Status:
Possibly Marketed Outside US
First approved in 2022
Source:
21 CFR 350
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Aconitic Acid found in leaves and tubers of Aconitum napellus L., Ranunculaceae, in various species of Achillea (Compositae) and Equisetum (Equisetaceae), in beet root, and in sugar cane. It is indicated for the temporary relief of symptoms of chronic illness including fatigue, effects of toxin buildup, slowed metabolism, weakened constitution. The limited data on trans-aconitic acid indicate it to be less toxic than citric acid. Trans-aconitate salts appear to be excreted readily by the kidneys. There is no direct evidence that trans-aconitic acid is utilized as is the cis-aconitic acid isomer in mammalian metabolism although non-specific oxidation probably occurs.
Status:
Possibly Marketed Outside US
Source:
NCT03237182: Phase 4 Interventional Terminated Tuberculosis, Multidrug-Resistant
(2017)
Source URL:
First approved in 2022
Source:
Kanamycin Sulfates by KDG Impresa LLC, Aqion
Source URL:
Class:
MIXTURE
Targets:
Kanamycin (a mixture of kanamycin A, B and C) is an aminoglycoside bacteriocidal antibiotic, available in oral, intravenous, and intramuscular forms, and used to treat a wide variety of infections. It is effective against Gram-negative bacteria and certain Gram-positive bacteria. Aminoglycosides work by binding to the bacterial 30S ribosomal subunit, causing misreading of t-RNA, leaving the bacterium unable to synthesize proteins vital to its growth. Serious side effects include tinnitus or loss of hearing, toxicity to kidneys, and allergic reactions to the drug. Mixing of an aminoglycoside with beta-lactam-type antibiotics (penicillins or cephalosporins) may result in a significant mutual inactivation. Even when an aminoglycoside and a penicillin-type drug are administered separately by different routes, a reduction in aminoglycoside serum half-life or serum levels has been reported in patients with impaired renal function and in some patients with normal renal function.
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.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333D
(2010)
Source URL:
First approved in 2009
Source:
21 CFR 333D
Source URL:
Class:
MIXTURE
Conditions:
Farnesol, (2E,6E)- is an isoprenoid found in many aromatic plants and is also produced in humans, where it acts on numerous nuclear receptors and has received considerable attention due to its apparent anticancer properties. Farnesol is present in many essential oils such as citronella, neroli, cyclamen, lemon grass, tuberose, rose, musk, balsam, and tolu. It is used in perfumery to emphasize the odors of sweet floral perfumes. Its method of action for enhancing perfume scent is as a co-solvent that regulates the volatility of the odorants. It is especially used in lilac perfumes. Farnesol is a natural pesticide for mites and is a pheromone for several other insects. In a 1994 report released by five top cigarette companies, farnesol was listed as one of 599 additives to cigarettes. Farnesol has been suggested to function as a chemopreventative and anti-tumor agent. Farnesol is subject to restrictions on its use in perfumery as some people may become sensitized to it, however, the evidence that farnesol can cause an allergic reaction in humans is disputed.
Status:
Possibly Marketed Outside US
First approved in 1999
Source:
21 CFR 358H
Source URL:
Class:
MIXTURE
Conditions:
Cetrimide is a quaternary ammonium compound. Cetrimide was first introduced as a combined cleanser and skin antiseptic by Barnes (1942). Cetrimide combines excellent detergent properties and minimal toxicity with a useful antiseptic action. Cetrimide affects membrane permeability allowing ‘leaking’ of essential cell constituents leading to cell death. This medication is a skin antiseptic and disinfectant prescribed for seborrhoeic dermatitis and wound cleansing. The cream has a bactericidal activity against gram-positive bacteria and incompatible with soaps and other anionic surfactants.
Status:
Possibly Marketed Outside US
Source:
Maltos-10 by Otsuka [Japan]
Source URL:
First approved in 1995
Source:
BLA103649
Source URL:
Class:
MIXTURE
Maltose, a disaccharide, is found mainly in grains and cereals. Nutritionally, maltose provides the same number of calories as starches and other sugars. Maltose can be the agent responsible for the primary signals to induce the sensations of hunger and satiation in human beings. It was shown, that parenterally administered maltose could be of clinical value.
Status:
Possibly Marketed Outside US
Class:
MIXTURE
Targets:
Conditions:
Kitasamycin (INN) is a macrolide antibiotic. It is produced by Streptomyces kitasatoensis. The drug has antimicrobial activity against a wide spectrum of pathogens. Kitasamycin Tartrate In 1953, HATA, et al. reported the isolation of a new antibiotic complex known as kitasamycin (leucomycin). The organism producing this antibiotic complex was obtained from soil samples and named Streptotnyces kitasatoensis HATA. In 1967, eight components were separated and their chemical structures determined. This antibiotic was approved by Ministry of Agriculture in 2001 as the growth promoter additive in poultry and swine to control and prevent digestive and respiratory diseases. Belonging to the macrolide antibiotic, its antibacterial activity is similar to tylosin, erythromycin, spiramycin and oleandomycin. The mode of action is to inhibit the protein synthesis process. Its inhibition spectrum includes Mycoplasmas, Gram-positive bacteria, some Gram-negative bacteria, Leptospira, Rickettsia. It also inhibits most bacteria resistant to penicillin, oxytetracycline, chlortetracycline, erythromycin and chloramphenicol bacteria strains. It is a safe and high efficacy growth-promoting additive for swine and poultry. Although this antibiotic was evaluated many years ago, it was felt of interest to determine its activity against recent isolates of gram-positive cocci. Consequently, the in vitro activity of kitasamycin was determined against 214 gram-positive cocci isolated from clinical specimens. Kitasamycin has activity against the vast majority of clinical isolates of S. aureus, Str. pyogenes and Dipl. pneumoniae, but in vitro studies do not suggest that it has any advantages over currently available antibiotics, although it would be expected to be effective in clinical situations in which erythromycin is indicated.
Status:
Possibly Marketed Outside US
Class:
MIXTURE
Targets:
Conditions:
Sulfomyxin is an antibacterial sulfonamide. It is intended for use in chickens and turkeys as an aid in the treatment of disease caused or complicated by E. coli, such as colibacillosis and complicated chronic respiratory disease.
Status:
US Approved Rx
(2019)
Source:
NDA211215
(2019)
Source URL:
First approved in 2000
Source:
NDA020873
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Bivalirudin is a synthetic 20 amino acid peptide rationally designed based on structural studies of hirudin, a naturally occurring anticoagulant. Bivalirudin is sold under the brand name Angiomax and is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). It is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin. Bivalirudin directly inhibits thrombin by binding simultaneously to its active catalytic site and its substrate recognition site.
Status:
US Approved Rx
(2024)
Source:
ANDA216113
(2024)
Source URL:
First marketed in 1921
Source:
Copper Sulphate U.S.P.
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Tetraamminecopper sulfate is a dark blue crystalline solid with a faint odor of ammonia. The primary hazard is the threat to the environment. Immediate steps should be taken to limit its spread to the environment. Used as a pesticide and fungicide, to print fabrics (especially in calico finishing), and to make other copper compounds.