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Status:
Possibly Marketed Outside US
Source:
SEROCION by Mironov, V.F. et al.
Source URL:
First approved in 2022
Source:
Incredible Saintete DishclothSoap by S-ONE PHARMACEUTICAL INC
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Propagermanium, a newly introduced hydrophilic polymer of 3-oxygermanium propionic acid (3,3’-(1,3- dioxo-1,3-digermoxanediyl) bispropionic acid) has been reported to have antiinflammatory, antiviral and antineoplastic properties. In Japan propagermanium is approved for the treatment of HBe positive chronic hepatitis B. A postmarketing survey, however, revealed the occurrence of moderate to severe liver damage after the treatment in about 4% of patients. In most countries propagermanium falls under the regulations of dietary supplements. An import alert on germanium products was imposed by the U.S. FDA in 1988, because of possible injury to health. In Germany governmental institutions warned consumers of possibly fatal kidney damage.
Status:
Possibly Marketed Outside US
First approved in 2022
Source:
21 CFR 350
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
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:
Urea Nitrogen Test System
Source URL:
First approved in 2022
Source:
Safe OPA by Valley Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
O-Phthalaldehyde (OPA) is a chemical reagent that forms fluorescent conjugation products with primary amines. It is used for the detection of many biogenic amines, peptides, and proteins in nanogram quantities in body fluids. O-Phthalaldehyde is approved by FDA for use in test systems to detect blood urea nitrogen (BUN) for the diagnosis and
treatment of certain renal and metabolic diseases.
OPA is also a known desinfectant and has been approved for high-level sterilization of heat-sensitive medical instruments and is increasingly being used as a replacement in the healthcare industry for glutaraldehyde. OPA has also been approved for use as an indoor antimicrobial pesticide; an intermediate for the synthesis of pharmaceuticals, medicines, and other organic compounds.
Status:
Possibly Marketed Outside US
Source:
LISSAMINE GREEN
Source URL:
First approved in 2021
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Acid green 50 (Lissamine Green B) is a synthetically produced organic acid dye with two aminophenyl groups. Acid green 50 is extensively used as a food dye and has a medical application as a staining agent. Due to its low toxicity and ability to stain dead and damaged cells the dye (in form of lissamine green strips) was approved as a tool for diagnosis of eye diseases associated with the damage of ocular surface epithelial cells.
Status:
Possibly Marketed Outside US
First approved in 2020
Source:
21 CFR 333C
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Dymanthine (Thelmesan) is an Anthelmintic, it is prepared as the hydrochloride and has some activity against hookworm infection, ascariasis, trichuriasis and hymenolepiasis. The drug appears to be safe, well tolerated and to cause few side effects (nausea, vomiting, headache, diarrhea, giddiness).
Status:
Possibly Marketed Outside US
Source:
NEXGARD
Source URL:
First approved in 2020
Source:
NADA141406
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Afoxolaner (brand name NexGard) is a member of an isoxazoline class of compounds, which is used to kill adult fleas and is indicated for the treatment and prevention of flea infestations, and the treatment and control of Black-legged tick, American Dog tick, Lone Star tick, and Brown dog tick infestations in dogs and puppies. Afoxolaner is a member of the isoxazoline family, shown to bind at a binding site to inhibit insect and acarine ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. Afoxolaner blocks native and expressed insect GABA-gated chloride channels with nanomolar potency. Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines.
Status:
Possibly Marketed Outside US
Source:
EchoGen by Sonus Pharmaceuticals
Source URL:
First approved in 2020
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Perflenapent (EchoGen, Sonus Pharmaceuticals, Bothel, WA, USA) is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left ventricular border delineation with resulting improvement in wall motion visualisation. EchoGen comprises liquid droplets of dodecafluoropentane stabilised by polyfluoroalkyl(polyoxyethylene)
ethanol and dispersed in an aqueous formulation containing sucrose. Dodecafluoropentane is the chemical name used to reflect the perflenapent/perflisopent mixture. Following activation and administration of
EchoGen, dodecafluoropentane microbubbles are formed. EchoGen should only be used in patients where the study without contrast enhancement is inconclusive. The European Commission has approved SONUS Pharmaceuticals' EchoGen (perflenapent emulsion) in all 15 countries of the European Union. EchoGen is a fluorocarbon-based ultrasound contrast agent which has been approved as a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease who have had previous inconclusive non-contrast studies. Additional approved labeling in the EU states that the use of EchoGen in spectral and color Doppler studies was shown to enhance the visualization of blood flow across mitral, aortic and tricuspid valves in a subset of patients. In 2000 SONUS Pharmaceuticals withdrew the NDA for EchoGen in the USA.
Status:
Possibly Marketed Outside US
Source:
ENTUMIN
Source URL:
First approved in 2020
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Clothiapine is a neuroleptic of dibenzoepine class that ise used for the treatment of mental disorders. It is supposed that clothiapine acts by blocking GABA (A) receptors. The drug is marketed in some European countries under the name Entumin.
Status:
Possibly Marketed Outside US
First approved in 2019
Source:
ANADA200610
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Domitor (medetomidine hydrochloride) is indicated for use in dogs: for restraint, sedation and analgesia associated with clinical examinations and procedures, minor surgery, pre-anaesthesia and as a premedicant before thiopentone-halothane general a naesthesiaand as a premedicant before general anaesthesia with propofol. In combination with butorphanol for sedation and analgesia, and as a premedicant prior to thiopentone anaesthesia. In cats: for restraint and sedation. Medetomidine is a potent and highly selective alpha2-adrenoreceptor agonist with both central and peripheral activity, and acting both presynaptically and postsynaptically. Its primary effects are sedative and analgesic resulting from its central depressant activity. It has no local anaesthetic properties. Like other compounds of its class there are secondary effects, including bradycardia. Blood pressure is increased but then returns to normal or just below. Body temperature is decreased in a dose dependent manner and intestinal motility is also reduced. The drug has been developed by Orion Pharma. It is currently approved for dogs in the United States, and distributed in the United States by Pfizer Animal Health and by Novartis Animal Health in Canada under the product name Domitor. The marketed product is a racemic mixture of two stereoisomers; dexmedetomidine is the isomer with more useful effects, and is now marketed as Dexdomitor.
Status:
Possibly Marketed Outside US
First approved in 2019
Source:
IGNITE YOUR PASSION by FLPHARMACEUTICALS LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Zinc aspartate is an approved drug, used to treat zinc deficiency in humans. Zinc aspartate regulates the production of the growth hormone and sex hormones (it is necessary for the production of sperm cells and egg cells). It reduces the body’s susceptibility to infections and allergies. It promotes the proper secretion of insulin by the pancreas. Zinc deficiency causes: disorders in the functioning of the skin, the digestive system, the nervous system, the immunological system, and the skeletal system. Significant zinc deficiency can cause dwarfism and genital underdevelopment. Zinc aspartate suppresses experimental autoimmune encephalomyelitis (EAE), an animal model for multiple sclerosis (MS), as well as effector T cell functions in vitro.