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Status:
Possibly Marketed Outside US
Source:
Acesulfame K by Hoechst
Source URL:
First approved in 2002
Source:
NDA022410
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Acesulfame is a non-nutritive sweetener Acesulfame potassium is a calorie-free artificial sweetener, also known as Acesulfame K or Ace K (K being the symbol for potassium), and marketed under the trade names Sunett and Sweet One. In the European Union, it is known under the E number (additive code) E950. It was discovered accidentally in 1967 by German chemist Karl Clauss at Hoechst AG (now Nutrinova). In chemical structure, acesulfame potassium is the potassium salt of 6-methyl-1,2,3- oxathiazine-4(3H)-one 2,2-dioxide. Acesulfame K has been approved for a variety of uses in more than 90 countries. In 1998, the FDA broadened the US approval of acesulfame K to allow its use in nonalcoholic beverages. It is often blended with sucralose and used to decrease the bitter aftertaste of aspartame. A wide range of low-calorie foods and drinks contain acesulfame K, including table-top sweeteners, chewing gum, jam, dairy products, frozen desserts, drinks and baked goods. Acesulfame K is not broken down when digested, nor is it stored in the body. After being consumed, it is quickly absorbed by the body and then rapidly excreted, unchanged.
Status:
Possibly Marketed Outside US
Source:
BRONZ REPAIR SEA AND TROPICS FACE SPF 25
Source URL:
First approved in 2002
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Status:
Possibly Marketed Outside US
Source:
Axona by Accera
Source URL:
First approved in 2002
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Tricaprylin is a triester of glycerin and caprylic acid. It is used as a fragrance ingredient, solvent, and primarily as an emollient in a variety of personal care products, including makeup, creams and lotions, deodorants, sunscreens, hair conditioners, and skin cleansers. Tricaprylin is an ingredient of Axona, a prescription medical food intended for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s disease. Axona provides a simple and safe method to induce hyperketonemia, thus providing an alternative energy substrate to glucose in the brain of patients with AD. After oral administration of Axona, Tricaprylin in Axona is processed by enzymes in the gut, and the resulting medium-chain fatty acids (MCFAs) are absorbed into the blood supply leading to the liver. The MCFAs rapidly pass directly to the liver, where they undergo oxidation to form ketones. Since the liver does not use ketones, they are released into the circulation to be used by nonliver tissues. Some ketones can cross the blood-brain barrier and are then taken up by brain cells. While glucose is the brain’s chief energy source, ketones normally serve as the "backup" energy source. Ketones the body produces after Axona is consumed, act as an alternative energy source for brain cells that have lost their ability to use glucose (sugar) as a result of Alzheimer’s disease.
Status:
Possibly Marketed Outside US
Source:
Meloxicam
Source URL:
First approved in 2002
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
DIMETHYL SULFONE is a compound that contains sulfur. It is a naturally occurring organosulfur compound utilized as a complementary and alternative medicine (CAM) under a variety of names including dimethyl sulfone, methyl sulfone, sulfonylbismethane, organic sulfur, or crystalline dimethyl sulfoxide. Its most common use is as anti-inflammatory agent. DIMETHYL SULFONE has been claimed to relieve stress, relieve pain, treat parasitic infections, increase energy, boost metabolism, enhance circulation, and improve wound healing, but there is little supporting scientific evidence. Due to its enhanced ability to penetrate membranes and permeate throughout the body, the full mechanistic function of MSM may involve a collection of cell types and is therefore difficult to elucidate. DIMETHYL SULFONE is recognized as safe by the FDA, but efficacy has yet to be proven. In rats, no adverse events were observed after daily doses of 2 g MSM per kg of body weight. Published clinical trials of DIMETHYL SULFONE did not report any serious side effects, but long-term effects are unknown.
Status:
Possibly Marketed Outside US
Source:
WHITE MALLOW DIAPER RASH CREAM
Source URL:
First approved in 2001
Source:
21 CFR 333E
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Conditions:
Status:
Possibly Marketed Outside US
Source:
NCT00449917: Phase 4 Interventional Completed Macular Pigment Optical Density
(2006)
Source URL:
First approved in 2001
Source:
Strovite OneCaplets by Exeltis USA, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Lutein is a xanthophyll and one of 600 known naturally occurring carotenoids. Lutein is synthesized only by plants and like other xanthophylls is found in high quantities in green leafy vegetables such as spinach, kale and yellow carrots. In green plants, xanthophylls act to modulate light energy and serve as non-photochemical quenching agents to deal with triplet chlorophyll (an excited form of chlorophyll), which is overproduced at very high light levels, during photosynthesis. Xanthophylls are taken for nutritional supplementation, and also for treating dietary shortage or imbalance. Xanthophylls have antioxidant activity and react with active oxygen species, producing biologically active degradation products. They also can inhibit peroxidation of membrane phospholipids and reduce lipofuscin formation, both of which contribute to their antioxidant properties. Lutein is naturally present in the macula of the human retina. It filters out potentially phototoxic blue light and near-ultraviolet radiation from the macula. The protective effect is due in part, to the reactive oxygen species quenching ability of these carotenoids. Lutein is more stable to decomposition by pro-oxidants than are other carotenoids such as beta-carotene and lycopene. Lutein is abundant in the region surrounding the fovea, and lutein is the predominant pigment at the outermost periphery of the macula. Zeaxanthin, which is fully conjugated (lutein is not), may offer somewhat better protection than lutein against phototoxic damage caused by blue and near-ultraviolet light radiation. Lutein is one of only two carotenoids that have been identified in the human lens, may be protective against age-related increases in lens density and cataract formation. Again, the possible protection afforded by lutein may be accounted for, in part, by its reactive oxygen species scavenging abilities. Carotenoids also provide protection from cancer. One of the mechanisms of this is by increasing the expression of the protein connexin-43, thereby stimulating gap junctional communication and preventing unrestrained cell proliferation. Lutein was found to be present in a concentrated area of the macula, a small area of the retina responsible for central vision. The hypothesis for the natural concentration is that lutein helps protect from oxidative stress and high-energy light. Several studies show that an increase in macula pigmentation decreases the risk for eye diseases such as Age-related Macular Degeneration (AMD). There is also epidemiological evidence that increasing lutein and zeaxanthin intake lowers the risk of cataract development. Consumption of more than 2.4 mg of lutein/zeaxanthin daily from foods and supplements was significantly correlated with reduced incidence of nuclear lens opacities, as revealed from data collected during a 13- to 15-year period in the Nutrition and Vision Project (NVP).
Status:
Possibly Marketed Outside US
First approved in 2001
Source:
NADA140951
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Diclazuril is a main component of veterinary drugs used for the treatment of coccidiosis (chickens, turkeys, rabbits, etc) and equine protozoal myeloencephalitis (horses). When used for the treatment of coccidiosis, it acts by causing the degeneration of schizonts and gamonts. While in the animals affected by protozoal myeloencephalitis the drug is believed to inhibit merozoite production. In vivo experiments on horses have shown that the drug may cross the blood brain barrier.
Status:
Possibly Marketed Outside US
First approved in 2001
Source:
ANDA077565
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Phenoxyisopropanol is used as an approved preservative. Protectol PP preservative is a mixture of 1- Phenoxy-2-propanol (phenoxyisopropanol) and 2-Phenoxy-1-propanol, is widely accepted around the world and is allowed as a preservative in cosmetics, toiletries and household products. Phenoxyisopropanol is a component of Clearasil daily face wash, used to prevent pimples, keep pores clear where pimples start, deep clean, remove dirt and oil.
Status:
Possibly Marketed Outside US
Source:
Econor by Novartis
Source URL:
First approved in 2001
Source:
Valnemulin Hydrochloride by Chemo Biosynthesis s.r.l.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Valnemulin (marketed under the trade name Econor) is a pleuromutilin antibiotic used to treat swine dysentery, ileitis, colitis and pneumonia. It is approved for veterinary use only. Valnemulin is an antibiotic belonging to the pleuromutilin group, which acts by the inhibition of the initiation of protein synthesis at the level of the bacterial ribosome. Valnemulin has activity against a range of bacteria including those responsible for enteric and respiratory disease in pigs. Valnemulin shows high activity against Mycoplasma spp. and spirochaetes such as Brachyspira hyodysenteriae and Brachyspira pilosicoli. Valnemulin has little activity against Enterobacteriaceae, such as Salmonella spp. and Escherichia coli. There appears to be no resistance development to valnemulin to date by M. hyopneumoniae and L. intracellularis. There have been some increases of MICs of valnemulin against B. hyodysenteriae and to a lesser degree B. pilosicoli, some of which appear to have developed resistance. Valnemulin binds to the ribosome and inhibits bacterial protein synthesis. Resistance development primarily occurs because of changes at the binding site associated with mutations of the ribosomal DNA genes. Econor 10% and 50% is indicated for: The treatment and prevention of swine dysentery. The treatment of clinical signs of porcine proliferative enteropathy (ileitis). The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd. Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10 - 12 mg/kg bodyweight lung lesions and weight loss are reduced, but infection with Mycoplasma hyopneumoniae is not eliminated. Econor 0.5% and 1% is indicated: For the treatment and prevention of swine dysentery. The treatment of clinical signs of porcine proliferative enteropathy (ileitis). The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd.
Status:
Possibly Marketed Outside US
Source:
NU SKIN AGELOC ME
Source URL:
First approved in 2000
Source:
M016
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
CERAMIDE NP (previously CERAMIDE 3) is a naturally occurring lipid and major component of the stratum corneum (outer skin layer). Levels of CERAMIDE NP decrease with advancing age. CERAMIDE NP is widely used as a moisturizer in cosmetic products because of its hydrating function. Interactions have been found with ceramide 1, synergistically improving the skin barrier function in humans, i.e. better skin hydration and less transepidermal water loss. There are no safety concerns for cosmetic products containing less than 1% CERAMIDE NP.