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Status:
Possibly Marketed Outside US
First approved in 2002
Source:
NADA141207
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Danofloxacin is a quinolone antibacterial agent for veterinary medicine. The drug is approved by FDA for the treatment of bovine infectious respiratory disease under the name Advocin (mesylate salt). Danofloxacin exerts its action by inhibiting bacterial DNA gyrase.
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:
NCT04475276: Phase 4 Interventional Recruiting Non-Alcoholic Fatty Liver Disease
(2021)
Source URL:
First approved in 2001
Source:
Strovite OneCaplets by Exeltis USA, Inc.
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Thioctic acid also known as alpha-lipoic acid is a dietary supplement, which is a common ingredient in OTC (over-the-counter) multivitamin formulas and anti-aging supplements. Thioctic acid exists in both R- and S-enantiomeric forms, however, only R-form is essential as a cofactor in biological systems (the acid is coupled via an amide linkage to a lysine of several multienzyme complexes, such as the pyruvate dehydrogenase complex, the alpha-ketoglutarate dehydrogenase complex, the glycine cleavage system and the branched-chain oxo acid dehydrogenase complex). Most commercially available thioctic acid supplements are a mixture of both R and S enantiomers or R-form alone. Several studies have shown that the acid has beneficial effect on diabetes complications, cancer, glaucome, liver disease, etc. The mechanisms of thioctic acid is related to its antioxidant properties, metal chelator properties, however, those mechanisms need futher confirmation.
Status:
Possibly Marketed Outside US
First approved in 2000
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Borneol, a monoterpenoid alcohol, is a component of many essential oils. Barneol occurs in nature as a single enantiomer (d- or l-, depending on the oil type) or, less frequently, as the racemate. Several studies have proved the effectiveness of borneol. In Chinese medicines borneol has been used in relieving symptoms of anxiety, fatigue and insomnia; inducing anesthesia and analgesia to alleviate abdominal pain, wounds and burns; relieving rheumatic pain, hemorrhoids, skin diseases and ulcerations of the mouth, ears, eyes or nose; to treat sore throats and skin infections, and is mainly used to treat cardiovascular and cerebrovascular diseases. Borneol has a significant therapeutic effect on neuralgia. This compound is considered a GRAS approved by the FDA as food flavor. Additionally, borneol is a fragrance ingredient. GABAA, TRPV3, TRPM8 and TRPA1 have been identified as the molecular targets of borneol.
Status:
Possibly Marketed Outside US
Source:
capstar by Takeda Chemical Industries
Source URL:
First approved in 2000
Source:
NADA141175
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Nitenpyram is a neonicotinoid, a neurotoxin that blocks neural messages and used in agriculture and veterinary medicine to kill external parasites of pets. Imidacloprid act as agonists at the insect nicotinic acetylcholine receptor (nAChR). The botanical insecticide nicotine acts at the same target without the neonicotinoid level of effectiveness or safety. Fundamental differences between the nAChRs of insects and mammals confer remarkable selectivity for the neonicotinoids. Whereas ionized nicotine binds at an anionic subsite in the mammalian nAChR, the negatively tipped ("magic" nitro or cyano) neonicotinoids interact with a proposed unique subsite consisting of cationic amino acid residue(s) in the insect nAChR. Nitenpyram was introduced into the United States in 1994 as a veterinary flea control treatment, structural pest and crop insecticide, and seed treatment. It has been used orally in dogs, cats, and some wildlife species for over 10 years. After ingestion, it begins killing adult fleas within 30 minutes, and effects continue for up to 48 hours. Though nitenpyram is used to kill adult fleas quickly on an infected animal, it does not kill insect eggs and has no long-term activity. Thus, it is not effective as a long-term flea preventative; however, it can be repeatedly applied over the course of several days to eradicate a single instance of infestation. Nitenpyram can be combined with a longer-term flea preventative like fipronil or lufenuron to prevent reinfestation. Neonicotinoids for veterinary use are considered to have a low order of toxicity for domestic animals and there are no reports of nitenpyram intoxication.
Status:
Possibly Marketed Outside US
First approved in 1999
Source:
NDA020954
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
N,N-Dimethylacetamide (DMA) is a multipurpose reagent which delivers its own H, C, N and O atoms for the synthesis of a variety of compounds under a number of different experimental conditions. N,N-Dimethylacetamide is a water-miscible solvent, FDA approved as excipient and therefore widely used as drug-delivery vehicle. It has been shown that DMA is epigenetically active since it binds bromodomains and inhibits osteoclastogenesis and inflammation. DMA has a potential as an anti-osteoporotic agent via the inhibition of osteoclast mediated bone resorption and enhanced bone regeneration. N,N-Dimethylacetamide is used as a polar solvent in organic synthesis as well as in reactions involving strong bases such as sodium hydroxide. N,N-Dimethylacetamide finds application as a reaction medium in the production of pharmaceuticals, agrochemicals, dyes and plasticizers. It is widely used in polymer industry due to its high solving power for high molecular-weight polymers and synthetic resins. It plays an important role as a catalyst in various reactions viz. cyclization, halogenation, cynidation, alkylation and dehydrogenation and increases the yield of main products. It is also used as an extracting agent for oil and gases, in paint removers, in the production of photo-resist stripping compounds and as booster solvent in coatings.
Status:
Possibly Marketed Outside US
First approved in 1997
Source:
NADA141081
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Orbifloxacin (brand name Orbax) is a fluoroquinolone antibiotic which is approved for use in dogs and cats, abd marketed by Schering-Plough Animal Health. Orbifloxacin is a synthetic broad-spectrum antibacterial agent from the class of fluoroquinolone carboxylic acid derivatives. Orbifloxacin is the international nonproprietary name for 1-cyclopropyl-5,6,8-trifluoro-1,4-dihydro-7-(cis-3,5-dimethyl-1-piperazinyl)-4-oxoquinoline-3-carboxylic acid. ORBAX® Oral Suspension is a malt flavored antibiotic suspension containing 30 mg/mL of orbifloxacin and sorbic acid as a preservative. ORBAX® Oral Suspension is indicated for the treatment of urinary tract infections (cystitis) and also for skin and soft tissue infections (wounds and abscesses). Orbifloxacin is bactericidal against a wide range of gram-negative and gram-positive organisms and exerts its antibacterial effect through interference with the bacterial enzyme DNA gyrase which is needed for the maintenance and synthesis of bacterial DNA.
Status:
Possibly Marketed Outside US
Source:
NCT04162834: Phase 4 Interventional Completed Kidney Cancer
(2019)
Source URL:
First approved in 1995
Source:
Papaverine Hydrochloride by American Regent, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
An alkaloid found in opium but not closely related to the other opium alkaloids in its structure or pharmacological actions. Papaverine is a vasodilating agent. Papaverine is used for the treating certain conditions that are accompanied by smooth muscle spasms (eg, blood vessel, urinary, gallbladder, or intestinal spasm). Papaverine is a nonxanthine phosphodiesterase inhibitor for the relief of cerebral and peripheral ischemia associated with arterial spasm and myocardial ischemia complicated by arrhythmias. The main actions of Papaverine are exerted on cardiac and smooth muscle. Like qathidine, Papaverine acts directly on the heart muscle to depress conduction and prolong the refractory period. Papaverine relaxes various smooth muscles. This relaxation may be prominent if spasm exists. The muscle cell is not paralyzed by Papaverine and still responds to drugs and other stimuli causing contraction. The antispasmodic effect is a direct one, and unrelated to muscle innervation. Papaverine is practically devoid of effects on the central nervous system. Papaverine relaxes the smooth musculature of the larger blood vessels, especially coronary, systemic peripheral, and pulmonary arteries. Papaverine is a potent, specific inhibitor of PDE10A. Papaverine for treatment of erectile dysfunction (ED) is excluded from coverage.
Status:
First approved in 1994
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Status:
Possibly Marketed Outside US
Source:
KLEER-PLEX ADVANCED ACNE CARE SYSTEM
Source URL:
First approved in 1994
Source:
ANDA077538
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Phenethyl alcohol, or 2-phenylethanol, is an aromatic alcohol with a rosy scent. It is widely used in the food, fragrance, and cosmetic industries. It is used in the formulation of eye area makeup, skin care products, shampoos, perfumes, and colognes. Promising sources of natural 2-phenylethanol are microorganisms, especially yeasts, which can produce it by biosynthesis and biotransformation.