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Status:
Possibly Marketed Outside US
First approved in 2007
Source:
NADA141275
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Emodepside is a semi-synthetic product (originated by Astellas and out-licensed to Bayer for animal and human use); its precursor is synthesized by a fungus living in the leaves of Camellia japonica. It is a potent antihelminthic drug used in combination with praziquantel (as Profender®) and in combination with toltrazuril (as Procox®) for the treatment of parasitic worms in cats and dogs. Emodepside, a semi-synthetic derivative of PF1022A, belongs to a new class of anthelmintic drugs, the cyclooctadepsipeptides, and shows good efficacy against macrocyclic lactone-, levamisole- or benzimidazole-resistant nematode populations. Although putative receptors for emodepside have already been discovered, its mode of action is still not fully understood. It has being suggested that GABA(A)-receptor UNC-49 is associated with the emodepside mode of action. It has also being shown that Emodepside binds to a presynaptic latrophilin receptor in nematodes. The following presynaptic signal transduction occurs via activation of Gqalpha protein and phospholipase-Cbeta, which leads to mobilization of diacylglycerol (DAG). DAG then activates UNC-13 and synaptobrevin, two proteins which play an important role in presynaptic vesicle-functioning. This finally leads to the release of a currently unidentified transmitter. The transmitter (or modulator) exerts its effects at the postsynaptic membrane and induces a flaccid paralysis of the pharynx and the somatic musculature in nematodes.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2006
Source:
21 CFR 333D
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Status:
Possibly Marketed Outside US
Source:
Zilpaterol hydrochloride
Source URL:
First approved in 2006
Source:
NADA141258
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Zilpaterol is an agonist of β2-adrenergic receptor. Zilpaterol exerts bronchospasmolytic action. Zilmax® (4.8% Zilpaterol hydrochloride) is used to increase rate of bodyweight gain, improve feed efficiency, and increase carcass leanness in cattle fed in confinement for a period of 20-40 consecutive days at the end of the feeding period before slaughter.
Status:
Possibly Marketed Outside US
First approved in 2006
Source:
Xylazine by GRINDEKS Joint Stock Company
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Xylazine was developed as an antihypertensive agent. During clinical studies in people xylazine was found to have excessive central nervous system depressant effects and it was subsequently introduced for veterinary use as a sedative, analgesic and relaxant. Xylazine is a potent alpha-2 adrenergic agonist. Xylazine in horses and Cervidae may occasionally cause slight muscle tremors, bradycardia with partial A-V heart block and a reduced respiratory rate. Movement in response to sharp auditory stimuli may be observed.
Status:
Possibly Marketed Outside US
First approved in 2005
Source:
NADA141229
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Romifidine is an alpha2-adrenergic agonist, which as a sedative and analgesic in horses. The drug was approved by FDA under the name Sedivet. It has no use in humans.
Status:
Possibly Marketed Outside US
Source:
PRISMASOL
Source URL:
First approved in 2005
Source:
ANDA076313
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Lactic Acid, L- (L-lactic acid, L-lactate) is the levorotatory isomer of lactic acid, the biologically active isoform in humans. Lactic acid or lactate is produced during fermentation from pyruvate by lactate dehydrogenase. Lactate dehydrogenase is isomer-specific so that production and metabolism of D-lactate require D-LDH and L-lactate requires L-LDH. Mammalian cells only contain L-LDH so that in humans the lactate produced is almost exclusively L-lactate. Carbohydrate-fermenting bacterial species (e.g. lactobacillus spp) have by contrast both enzymes and therefore the capacity to produce both D-lactate and L-lactate. L-lactic acid is the primary agonist of hydroxycarboxylic acid receptor 1 (HCA1), which is a Gi/o-coupled G protein-coupled receptor (GPCR). Poly-L-lactic acid is an absorbable, semi-permanent, injectable implant that can be used to restore volume and stimulate collagen formation gradually. It is FDA-approved for the correction of facial fat loss associated with antiretroviral therapy-induced lipoatrophy in HIV patients. It is FDA-approved for use in immunocompetent people for the correction of nasolabial fold deficiencies and other facial wrinkles. It has been used off-label to enhance the cheeks, hands, neck, thighs, gluteal enhancement and chest wall deformities, such as pectus excavatum or thoracic deformities secondary to surgical procedures.
Status:
Possibly Marketed Outside US
Source:
NCT04677712: Phase 4 Interventional Completed Edematous Fibrosclerotic Panniculopathy (EFP)
(2020)
Source URL:
First approved in 2004
Source:
Salex by Coria Laboratories
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Phenoxyethanol, also known as Ethylene Glycol Monophenyl Ether, is a glycol ether and bactericide (that functions as a disinfectant, antiseptic or antibiotic) that is primarily used as a preservative in cosmetics and beauty products. It is used as a preservative in vaccines. Phenoxyethanol is included in topical antiseptic solutions, like octenisept used for the treatment of traumatic, acute, chronic, surgical and burn wounds, the treatment of bacterial vaginosis, acne lesions and as the mucous membrane antiseptic.
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 2000
Source:
BACMIN by Marnel Pharmaceuticals, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Flavone belongs to the class of organic compounds known as flavones. Flavones are mainly found in cereals and herbs. Flavone is a less potent inhibitor of CYP1A1 than CYP1A2. Flavone inhibited the estrogen action without binding to the estrogen receptor by acting as a competitive agonist for aryl hydrocarbon receptor. This naturally occurring flavone was shown to be an effective inducer of benzpyrene hydroxylase in human liver microsomes in in vitro assays, and the inducing effect of the flavone was concentration-dependent.