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Status:
Possibly Marketed Outside US
Source:
SAFYRAL
Source URL:
First approved in 2010
Source:
Zatean-Pn DHA by Trigen Laboratories, LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
For people with MTHFR gene variations, supplementing with the already activated form of folate (5-MTHF/5- METHYLTETRAHYDROFOLATE/LEVOMEFOLIC ACID) is far more effective in providing this form of folate than introducing the pre-converted form to the body through typical folate supplements. L-Methylfolate (5-MTHF) supplements provide the active form of folate naturally present in the body and available for biological action. 5-MTHF—the “active” form of folate that is able to pass the blood brain barrier. However, without a properly functioning methylenetetrahydrofolate reductase, MTHFR this conversion cannot take place and folate is not converted to forms that can cross the blood brain barrier. That is where 5-MTHF supplements come in. Levomefolate calcium is structurally identical to L-5-methyltetrahydrofolate (L-5-methyl-THF), a metabolite of vitamin B9. Mean baseline concentrations of about 15 nmol/L are reached in populations without folate food fortification under normal nutritional conditions. Orally administered levomefolate calcium is absorbed and is incorporated into the body folate pool. Peak plasma concentrations of about 50 nmol/L above baseline are reached within 0.5 – 1.5 hours after single oral administration of 0.451 mg levomefolate calcium. Steady state conditions for total folate in plasma after intake of 0.451 mg levomefolate calcium. In red blood cells, achievement of steady state is delayed due to the long lifespan of red blood cells of about 120 days. Levomefolate calcium is a part of contraceptive tablets: SAFYRA. Safyral is an estrogen/progestin COC (Combined Oral Contraceptive) containing a folate, indicated for use by women to: prevent pregnancy and raise folate levels in women who choose to use an oral contraceptive for contraception. COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
Status:
Possibly Marketed Outside US
Source:
HERBALIFE SKIN 7 DAY RESULTS KIT
Source URL:
First approved in 2010
Source:
21 CFR 333B
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Hexylene glycol is a small molecular weight surfactant. Hexylene Glycol is a solvent and viscosity agent used in many skin care products. Hexylene Glycol is a solvent and viscosity agent used in many skin care products. It is used to thin out heavy compositions and create a thinner, more spreadable product. Hexylene Glycol is a solvent and viscosity agent used in many skin care products. Hexylene glycol is used in the formulation of hair and bath products, eye and facial makeup, fragrances, personal cleanliness products, and shaving and skin care products. Hexylene glycol is widely used in the coating industry as a component for lacquers, varnishes, printing inks and both oil and water-based paints. Although the FDA has approved Hexylene Glycol and the CIR found it an acceptable solvent in skin care products, some studies have shown that it is an irritant.
Status:
Possibly Marketed Outside US
First approved in 2010
Source:
NADA138952
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Narasin is a polyether carboxylic ionophore agent that is authorised in Europe according to Commission Regulation No (EC) 1464/2004 as a coccidiostat for use in chickens for fattening with a maximum content of the active substance in feed of 70 mg/kg and a withdrawal period of one day. Narasin is the active ingredient in Monteban, a premix that is incorporated into chicken feed. Narasin is already approved for continuous oral use as Monteban (NADA 118-980) in chicken feed for the prevention of coccidiosis at doses up to 80 mg narasin/kg feed. Narasin is produced by the fermentation of a strain of Streptomyces aureofaciens.The biological activity of narasin is based on its ability to form lipid soluble and dynamically reversible complexes with cations, preferably monovalent cations such as alkaline K+, Na+ and Rb+: Narasin functions as a carrier of these ions, mediating an electrically neutral exchangediffusion type of ion transport across the membranes. The resultant changes in transmembrane ion gradients and electrical potentials produce critical effects on cellular function and metabolism of coccidia. Narasin is effective against sporozoites and early and late asexual stages of coccidia in broilers caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati, E. necatrix and E. tenella. Narasin also is used for prevention of necrotic enteritis in broiler chicken. Narasin was identified and characterized as a novel agent that inhibits DENV replication in vitro through non-cytotoxic mechanisms, thus indicating its potential to be further developed as a therapeutic anti-DENV agent.
Status:
Possibly Marketed Outside US
Source:
NCT04677712: Phase 4 Interventional Completed Edematous Fibrosclerotic Panniculopathy (EFP)
(2020)
Source URL:
First approved in 2010
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Caprylyl glycol (1,2-octanediol) is a diol derived from caprylic acid, a saturated fatty acid found some plants (coconut and palm oils) and animals (some mammals). Caprylyl glycol is a medium chain triglyceride known to have antibactieral, antifungal and anti-inflamatory properties. Caprylyl glycol is used in cosmetics, sun screens, cleansers and mositurizers as a skin conditioner, humectant (to reduce moisture loss) and stabilizer.
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
Source:
Unknown by Cope, A.C.|Hofmann, C.M.|Wyckoff, C.|Hardenbergh, E.
Source URL:
First approved in 2010
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Drometrizole is a benzotriazole derivative used as an ultraviolet (UV) light absorber and stabilizer in cosmetics. Drometrizole is used widely as a UV absorber and stabilizer in plastics, polyesters, celluloses, acrylates, dyes, rubber, synthetic and natural fibers, waxes, detergent solutions, and orthodontic adhesives. It is similarly used in agricultural products and insecticides. Drometrizole is approved as an indirect food additive for use as an antioxidant and/or stabilizer in polymers. Short-term studies using rats reported liver weight increases, increases in the activities of enzymes aminopyrine N-demethylase, and UDP glucuronosyl- transferase, but no significant effects were noted in the activities of acid hydrolases or in hepatocyte organelles. Drometrizole and products containing Drometrizole were nontoxic in acute oral, inhalation, and dermal studies using animals. Although there are case reports in which Drometrizole was considered the sensitizing agent, clinical tests of cosmetic products containing 0.03% to 1.0% Drometrizole produced no irritation, sensitization, photosensitization, or phototoxicity in a total of 436 subjects.
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 (Stereo):
CHEMICAL (ACHIRAL)
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:
Synanthic Bovine Dewormer by Coopers
Source URL:
First approved in 2010
Source:
NADA140854
Source URL:
Class (Stereo):
CHEMICAL (UNKNOWN)
Oxfendazole is a broad spectrum benzimidazole anthelmintic. Oxfendazole has broad-spectrum activity against inhibited larval
stages of gastrointestinal roundworms, tapeworms, and lungworms in many animal species at doses between 4.5–10 mg/kg.
Status:
Possibly Marketed Outside US
Source:
Enada by Birkmayer, G.D.
Source URL:
First approved in 2010
Source:
Bonogenhair care shampoo by Bonogen Co., Ltd
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
NADIDE (NAD+) is a coenzyme composed of ribosylnicotinamide 5'-diphosphate coupled to adenosine 5'-phosphate by pyrophosphate linkage. NADIDE was marketed under the brand name Enada. Although Enada (NADH) is marketed as a nutritional supplement, Birkmayer
Pharmaceuticals has launched two clinical trials to prove scientifically that Enada is effective.
Before these studies could get started they had to also prove to the Food and Drug Administration (FDA) that the stable oral form of Enada (NADH) is a safe substance.
Since the mid-‘80s more than 3,000 parkinsonian patients have received NADH, either as
intravenous infusion or in the form of oral tablets. Enada (NADH) is the world‘s first and only stabilized, absorbable, patented, tablet-form
NADH dietary supplement. It is now available to everyone whose lifestyle demands increased
energy, vitality and mental clarity. In other words, it is beneficial not only for patients
suffering from chronic fatigue syndrome, Alzheimer‘s disease, depression or Parkinson‘s
disease, but for any normal, healthy individual whose lifestyle demands more energy. NADIDE (NADH) may be considered as a therapeutic adjunct for
cancer patients to protect them against the general toxic effects of substances such as
doxorubicin or cisplatin by stimulating the DNA repair system and by promoting normal cellular
biosynthetic responses after chemotherapy. NADH seems to exhibit a chemo preventive effect.
Status:
Possibly Marketed Outside US
Source:
Cover Fx Mattifying Prime And Set
Source URL:
First approved in 2010
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Ethyl oleate is a fatty acid ester used as a solvent for pharmaceutical drug preparations involving lipophilic substances such as steroids. In vivo studies have demonstrated that Ethyl oleate and other fatty acid esters are also rapidly hydrolyzed to ethanol and free fatty acid. Ethyl oleate is one of the fatty acid ethyl esters (FAEE) that is formed in the body after ingestion of ethanol. There is a growing body of research literature that implicates FAEEs such as ethyl oleate as the toxic mediators of ethanol in the body (pancreas, liver, heart, and brain). Among the speculations is that ethyl oleate may be the toxic mediator of alcohol in fetal alcohol syndrome. The oral ingestion of ethyl oleate has been carefully studied and due to rapid degradation in the digestive tract, it appears safe for oral ingestion. Ethyl oleate is not currently approved by the U.S. Food and Drug Administration for any injectable use. However, it is used by compounding pharmacies as a vehicle for intramuscular drug delivery, in some cases to prepare the daily doses of progesterone in support of pregnancy. Studies which document the safe use of ethyl oleate in pregnancy for both the mother and the fetus have never been performed.