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Search results for m root_references_citation in Reference Text / Citation (approximate match)
Status:
Possibly Marketed Outside US
Source:
21 CFR 358A
(1992)
Source URL:
First approved in 1992
Source:
21 CFR 358A
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Glabridin is an isoflavane found in the root extract of licorice (Glycyrrhiza glabra). Glabridin is considered to be a phytoestrogen and has been associated with numerous biological properties ranging from antioxidant, anti-inflammatory, neuroprotective, anti-atherogenic effects, to the regulation of energy metabolism, but also including anti-tumorigenic, anti-nephritic, antibacterial and skin-whitening activities. A glabridin-enriched extract is widely used in a cosmetic formulation as anti-inflammatory, antioxidant and skin whitening agent. Anti-inflammatory action of glabridin is linked to downregulation of NF-κB, AP-1 and MAPKS signaling. Glabridin-induced attenuation of atherosclerosis is related to a reduction in macrophages-associated oxidation of low-density lipoprotein.
Status:
Possibly Marketed Outside US
First approved in 1982
Source:
NADA113645
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
p-Chlorocresol (p-chloro-m-cresol; PCMC; brand name: Preventol CMK) possesses disinfectant and antiseptic properties. Chlorocresol is used in various preparations for skin disinfection and wounds. It also used as a preservative in creams and other preparations for external use which contain water. For use as a disinfectant such as a hand wash, it is commonly dissolved in alcohol in combination with other phenols. It is a moderate allergen for sensitive skin. Chlorocresol produces potentially life-threatening effects which include dermatitis, which are responsible for the discontinuation of chlorocresol therapy. The symptomatic adverse reactions produced by chlorocresol are more or less tolerable and if they become severe, they can be treated symptomatically, these include hypersensitivity reactions, irritation of eyes.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2012)
Source URL:
First approved in 1948
Source:
ANDA209662
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Neotame is a derivative of a dipeptide compound of the amino acids - aspartic acid and phenylalanine. Neotame has been developed as a sweetener with a high degree of sweetness and is obtained by N-alkylating aspartame. Its degree of sweetness varies according to the kind of food and blend composition. It is 7000 to 13,000 times and about 30 to 60 times sweeter than sugar and aspartame respectively. Neotame is rapidly metabolized, completely eliminated and does not accumulate in the body. The major metabolic pathway of neotame is hydrolysis of the methyl ester by esterase which is present throughout the body. This yields de-esterified neotame, the major metabolite and a significant amount of methanol. Due to the presence of the 3-3-di-methylbutyl group, peptidases which would typically break the peptide bond between the aspartic acid and phenylalanine moieties are essentially blocked, thus reducing the availability of phenylalanine. Neotame was approved by the USFDA as a general purpose sweetener in July 2002
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (RACEMIC)
Erdosteine is an antioxidant compound developed by Edmond Pharma and approved in Europe for the treatment of chronic bronchitis and COPD. Erdosteine has two thiol groups and is believed to act as a free radicals scavenger (through the formation of the active metabolite I, N-thiodiglycolylhomocysteine). Also the drug effect may be due to the inhibition of the activity of elastase enzyme and its interaction with mucosa. The drug got Orphan Drug designation by FDA for the treatment of bronchiectasis.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Mizolastine (Mizollen) is a long-acting H1 -antihistamine indicated for the symptomatic relief of seasonal allergic rhinoconjunctivitis (hay fever), perennial allergic rhinoconjunctivitis and urticaria. It blocks H1 receptors and is commonly fast-acting. It does not prevent the actual release of histamine from mast cells, just prevents it binding to receptors. Side effects can include dry mouth and throat
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
TIANEPTINE, a tricyclic antidepressant, is a drug used for the treatment of the major depressive disorder. It was discovered by The French Society of Medical Research in the 1980s. Unlike other tricyclic antidepressants, TIANEPTINE is a selective serotonin reuptake enhancer with minimal effects on norepinephrine and dopamine uptake. Also, it is a full agonist at the mu-opioid and delta-opioid receptors with no effect at the kappa-opioid receptors. Selective mu-opioid agonists typically induce euphoria, which may contribute to TIANEPTINE's antidepressant effect. It is marketed as Coaxil/Stablon in many European countries, but it is not available in the US.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Rociletinib is a novel, potent, small molecule, third generation TKI that irreversibly binds and inhibits EGFR with the common activating (L858R, Del19) and T790M resistance mutations. The proposed indication of rociletinib is for the treatment of patients with mutant EGFR NSCLC who have been previously treated with an EGFR-targeted therapy and have the T790M mutation as detected by an FDA approved test. The results from two Phase 2 studies show that rociletinib 625 mg BID treatment has a favorable benefit:risk profile in patients with recurrent T790M-positive mutant EGFR NSCLC based on clinically meaningful and durable responses and a well-established and acceptable safety profile in this patient population with terminal lung cancer. In May 2016, Clovis Oncology, Inc. announced it has terminated enrollment in all ongoing sponsored studies of rociletinib, including TIGER-3, after the company was notified at meeting with the FDA that it could anticipate receiving a Complete Response Letter (CRL) for the rociletinib NDA on or before the PDUFA date of June 28, 2016. Clovis has also withdrawn its Marketing Authorization Application of rociletinib with European regulatory authorities.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Tasosartan is a long-acting angiotensin II (AngII) receptor blocker. Tasosartan is infrequently in the treatment of hypertension and heart failure. The manufacturer withdrew it from FDA review after phase III clinical trials showed elevated transaminases. Tasosartan blocks the renin-angiotensin-aldosterone system (RAAS) at the level of the AT1 receptor that mediates most, if not all, of the important actions of Ang II. Tasosartan binds reversibly to the AT1 receptors in vascular smooth muscle and the adrenal gland. As angiotensin II is a vasoconstrictor, which also stimulates the synthesis and release of aldosterone, blockage of its effects results in decreases in systemic vascular resistance.
Status:
Possibly Marketed Outside US
Source:
LY53857 maleate
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Zatosetron is a potent, selective, orally effective 5HT3 receptor antagonist. It has been studied in the treatment of emesis, migraine and anxiety.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Naphthalene is a crystalline aromatic hydrocarbon usually obtained by distillation of coal tar. Once used as a moth repellent, it is now important as a reactant in the production of phthalic anhydride, which in turn is used for making plasticizers, alkyd resins, and polyester resins. Other fumigant uses of naphthalene include use in soil as a fumigant pesticide, and in attic spaces to repel animals. In the past, naphthalene was administered orally to kill parasitic worms in livestock. In humans, exposure to large amounts of naphthalene may damage or destroy red blood cells. Humans, particularly children, have developed this condition after ingesting mothballs or deodorant blocks containing naphthalene. Some of the symptoms of naphthalene poisoning are fatigue, lack of appetite, restlessness, and pale skin. Exposure to large amounts of naphthalene may also cause nausea, vomiting, diarrhea, blood in the urine, and jaundice (yellow coloration of the skin).