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Status:
US Previously Marketed
Source:
AMIFOSTINE by EUGIA PHARMA SPECLTS
(2017)
Source URL:
First approved in 1995
Source:
ETHYOL by COSETTE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Amifostine is an organic thiophosphate cytoprotective agent known chemically as 2-[(3¬ aminopropyl)amino]ethanethiol dihydrogen phosphate (ester), it’s adjuvant used in cancer chemotherapy and radiotherapy involving DNA-binding chemotherapeutic agents. It is marketed under the trade name Ethyol. Amifostine is a prodrug and is dephosphorylated by alkaline phosphatase in tissues to a pharmacologically active free thiol metabolite. This metabolite is believed to be responsible for the reduction of the cumulative renal toxicity of cisplatin and for the reduction of the toxic effects of radiation on normal oral tissues. The ability of Ethyol to differentially protect normal tissues is attributed to the higher capillary alkaline phosphatase activity, higher pH and better vascularity of normal tissues relative to tumor tissue, which results in a more rapid generation of the active thiol metabolite as well as a higher rate constant for uptake into cells. The higher concentration of the thiol metabolite in normal tissues is available to bind to, and thereby detoxify, reactive metabolites of cisplatin. This thiol metabolite can also scavenge reactive oxygen species generated by exposure to either cisplatin or radiation. Healthy cells are preferentially protected because amifostine and metabolites are present in healthy cells at 100-fold greater concentrations than in tumor cells.
Status:
US Previously Marketed
Source:
Cedax
(1995)
Source URL:
First approved in 1995
Source:
Cedax
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Ceftibuten is a 3rd generation cephalosporin that is FDA approved for the treatment of acute bacterial exacerbations of chronic bronchitis, acute bacterial otitis media, pharyngitis and tonsillitis. Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall. This binding leads to inhibition of cell-wall synthesis. Common adverse reactions include diarrhea, nausea, vomiting and headache. The effect of increased gastric pH on the bioavailability of ceftibuten was evaluated in 18 healthy adult volunteers. Each volunteer was administered one 400-mg ceftibuten capsule. A single dose of liquid antacid did not affect the Cmax or AUC of ceftibuten; however, 150 mg of ranitidine q12h for 3 days increased the ceftibuten Cmax by 23% and ceftibuten AUC by 16%.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(23)(i) internal analgesic salsalate
Source URL:
First approved in 1995
Source:
Salsalate by Caraco Pharmaceutical Laboratories, Ltd.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Salsalate is a dimer of salicylic acid. Upon administration, it is metabolically hydrolyzed to salicylic acid. Salsalate is is a nonsteroidal anti-inflammatory agent for oral administration for treatment of rheumatoid arthritis, osteoarthritis and related rheumatoid disorders. In addition, salsalate is investigated for treatment of type 2 diabetes.
Status:
Possibly Marketed Outside US
Source:
Canderel by Schlatter, J.M.
Source URL:
First approved in 1995
Source:
ANDA210465
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Aspartame (l-aspartyl-l-phenylalanine methyl ester) known to the public as NutraSweet has been the subject of controversy since it first became an ingredient in food products. The perceived sweetness of aspartame in humans is due to its binding of the heterodimer G-protein coupled receptor formed by the proteins TAS1R2 and TAS1R3. Aspartame was used in experiments on animals to study its role in delays of osteoarthritis. It was shown, that aspartame improved bone cortical density and muscle mass, and might contribute to a better quality of life for these diseased animals. In addition, was investigated the effect in patients with sickle cell anemia. It was revealed, that oral administration of aspartame lead inhibition of sickle cells. That effect was explained by binding aspartame with two human Bence Jones proteins: Mcg and Sea. Thus was suggested, that aspartame could interfere with sickle hemoglobin fibril formation. Then several studies showed that aspartame had no effect on the polymerization of sickle hemoglobin.
Status:
Possibly Marketed Outside US
Source:
NCT01882218: Phase 4 Interventional Withdrawn Hepatic Cancer
(2012)
Source URL:
First approved in 1995
Source:
ANDA074076
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Galactose, a monosaccharide sugar, is a key source of energy and is an important compound for early human development. Galactose is present in dairy products, the pectin of some fruits, vegetables, and some herbs. Children get most of their dietary galactose from milk. D-galactose is freely available in health food stores and is promoted for stimulating the immune system and improving gut motility in healthy individuals. Galactose as a part of food supplement participates in phase II of clinical trials for congenital disorders of glycosylation (CDG) patients. CDG is a group of more than 130 inborn errors of metabolism affecting N-linked, O-linked protein and lipid-linked glycosylation. In addition, monosaccharide is used in clinical trials phase I in patients with focal segmental glomerulosclerosis (FSGS), where the galactose lowers the level of a circulating factors that increase glomerular permeability to albumin in patients with resistant FSGS.
Status:
Possibly Marketed Outside US
Source:
Maltos-10 by Otsuka [Japan]
Source URL:
First approved in 1995
Source:
BLA103649
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
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
Source:
ANDA203078
(1995)
Source URL:
First approved in 1995
Source:
ANDA203078
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
First approved in 1995
Source:
NDA020551
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Benzenesulfonic acid (conjugate base benzenesulfonate) is the simplest aromatic sulfonic acid, that is soluble in water and ethanol, slightly soluble in benzene and insoluble in nonpolar solvents like diethyl ether. Benzenesulfonic acid was first obtained, together with diphenyl sulfone, by E. MITSCHERLICH in 1834 by heating benzene with fuming sulfuric acid. The industrially important reaction of benzenesulfonic acid with alkali hydroxide to form phenol (alkali fusion) was developed by A. WURTZ and A. KEKUL_e in 1867 and by P. O. DEGENER in 1878. Until the early 1960s benzenesulfonic acid was used chiefly in the manufacture of phenol. Benzenesulfonic acid has the characteristic reactions of a strong aromatic sulfonic acid. Acid hydrolysis at 175 C splits it into benzene and sulfuric acid. Additional sulfonation with fuming sulfuric acid gives 1,3-benzenedisulfonic acid, which reacts further to 1,3,5-benzenetrisulfonic acid, and also diphenyl sulfone disulfonic acid. Benzenesulfonic acid is used as an acid catalyst. The sodium salt is used to standardize dyes. A variety of pharmaceutical drugs are prepared as benzenesulfonate salts and are known as besilates (INN) or besylates (USAN).
Status:
Possibly Marketed Outside US
Source:
Volu-Firm
Source URL:
First approved in 1995
Class (Stereo):
CHEMICAL (ACHIRAL)
Sodium myristate is the sodium salt of myristic acid. It is used in the food as the binder, emulsifier and anticaking agent. It is one of the commonly occurring soaps. It is used in cosmetic as a cleansing and emulsifying agent.
Status:
Possibly Marketed Outside US
Source:
BREAK FREE
Source URL:
First approved in 1995
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions: