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Search results for "SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS" in comments (approximate match)
Status:
Possibly Marketed Outside US
First approved in 2016
Source:
NADA141452
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Sarolaner is a member of the isoxazoline class of parasiticides. It is sold under the brand name Simparica, indicated for the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and
Rhipicephalus sanguineus), as well as of flea infestations (Ctenocephalides felis and Ctenocephalides canis) in dogs. The primary target of
action of sarolaner in insects and acarines is functional blockade of ligand-gated chloride channels
(GABA-receptors and glutamate-receptors). Sarolaner blocks GABA- and glutamate-gated chloride
channels in the central nervous system of insects and acarines. Disruption of these receptors by
sarolaner prevents the uptake of chloride ions by GABA and glutamate gated ion channels, thus
resulting in increased nerve stimulation and death of the target parasite. Sarolaner exhibits higher
functional potency to block insect/acarine receptors compared to mammalian receptors.
Status:
Possibly Marketed Outside US
Source:
POULTRYSULFA Soluble Powder by Merck
Source URL:
First approved in 2016
Source:
NADA100094
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Sulfaquinoxaline is a veterinary drug, which can be given to animals to treat coccidiosis and Acute Fowl cholera. It has often used in combinations with others drugs. It had its origins in the chemical synthetic program that sprang from the introduction of sulfonamide drugs into human medicine in the 1930s. The program was sustained through the years of World War II despite declining clinical use of that chemical class. Several sulfa drugs were known to be active against the sporozoan parasite (Plasmodium spp.) that causes malaria, but were not satisfactory in clinical practice. A sulfonamide that had a long plasma half-life would ipso facto be considered promising as an antimalarial drug. Sulfaquinoxaline, synthesized during the war, was such a compound. It proved too toxic to be used in human malaria, but was found to be a superior agent against another sporozoan parasite, Eimeria spp., the causative agent of coccidiosis in domestic chickens. In 1948 sulfaquinoxaline was introduced commercially as a poultry coccidiostat. The action mechanism of sulfaquinoxaline is to inhibit the dihydrofolate synthetase to encumber the nucleate synthesis of bacterium and coccidian its active peak to coccidian is at the second schizont stage (the fourth day of coccidial life cycle), so it will not affect the anti-coccidial immunity in chicken.
Status:
Possibly Marketed Outside US
Source:
MARQUIS
Source URL:
First approved in 2015
Source:
NADA141188
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Ponazuril, sold by the Bayer Corporation under the trade name Marquis, was the first FDA-approved treatment for equine protozoal myeloencephalitis (EPM) in horse, caused by Sarcocystis neurona. Also this drug was used in animals such as cats, dogs against coccidia, an intestinal parasite. Coccidia treatment is far shorter than treatment for EPM.
Status:
Possibly Marketed Outside US
Source:
DERAMAXX (deracoxib) by Searle
Source URL:
First approved in 2015
Source:
NADA141203
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Deracoxib (trade name Deramaxx, Novartis) is a non-steroidal anti-inflammatory drug of the coxib class, used in veterinary medicine for the control of postoperative pain and inflammation associated with orthopedic and dental surgery and for the control of pain and inflammation associated with osteoarthritis in dogs. Data indicate that deracoxib inhibits the production of PGE1 and 6-keto PGF1 by its inhibitory effects on prostaglandin biosynthesis. Deracoxib was shown to have antitumor effect against transitional cell carcinoma of the urinary bladder.
Status:
Possibly Marketed Outside US
Source:
Bravecto by Nissan Chemical Industries
Source URL:
First approved in 2014
Source:
NADA141426
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Fluralaner, isoxazoline class compound, is a systemic insecticide and acaricide with antiparasitic activity against cat and dog fleas and ticks. Fluralaner is an inhibitor of the arthropod nervous system. Fluralaner inhibits γ-aminobutyric acid (GABA)-gated chloride channels (GABACls) and L-glutamate-gated chloride channels (GluCls). Potency of fluralaner is comparable to fipronil (a phenylpyrazole ectoparasiticide). The U.S. Food and Drug Administration (FDA) approved it under the trade name Bravecto for flea and tick treatment and prevention in dogs in May 2014. Bravecto kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)] in dogs and puppies 6 months of age and older. Bravecto is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations in dogs and puppies 6 months of age and older.
Status:
Possibly Marketed Outside US
Source:
NCT03044652: Phase 4 Interventional Completed Vulvovaginal Atrophy
(2016)
Source URL:
First approved in 2014
Source:
NADA141325
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Estriol (E3), also spelled oestriol, is a steroid, a weak agonist of the estrogen receptors ERα and ERβ., and a minor female sex hormone. According to in vitro study, the relative binding affinity (RBA) of estriol for the human ERα and ERβ was 11.3% and 17.6% of that estradiol, respectively, and the relative transactivational capacity of estrone at the ERα and ERβ was 10.6% and 16.6% of that of estradiol, respectively. Estriol is marketed widely in Europe and elsewhere throughout the world under the brand names Ovestin, Ortho-Gynest, and a variety of others. It is available in oral tablet, vaginal cream, and vaginal suppository form, and is used in menopausal hormone therapy for the treatment of menopausal symptoms. Estriol is also available in some countries as estriol succinate (brand name Synapause), a dosage-equivalent ester prodrug of estriol. Estriol and estriol succinate are not approved for use in the United States and Canada, although they have been produced and sold by compounding pharmacies in North America for use as a component of bioidentical hormone therapy. Estriol can be measured in maternal blood or urine and can be used as a marker of fetal health and well-being. If levels of unconjugated estriol (uE3 or free estriol) are abnormally low in a pregnant woman, this may indicate chromosomal or congenital anomalies like Down syndrome or Edward's syndrome. It is included as part of the triple test and quadruple test for antenatal screening for fetal anomalies.
Status:
Possibly Marketed Outside US
First approved in 2013
Source:
NADA038233
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Zeranol is a non-steroidal anabolic growth promoter with potent estrogenic activity that is widely used as a growth promoter in the US beef industry. It is a mycotoxin, derived from fungi in the Fusarium family, it is an estrogen agonist. Zeranol is approved for use as a growth promoter in livestock, including beef cattle, in the United States. In Canada, it is approved for use in beef cattle only. Zeranol was officially banned in Europe due to safety concerns because of its potential carcinogenic and endocrine-disrupting biological activity. Merck Animal Health markets zeranol under the brand name Ralgro. It has being shown, that zeranol may increase cancer cell proliferation in already existing breast cancer.
Status:
Possibly Marketed Outside US
First approved in 2013
Source:
NADA141344
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Pradofloxacin (trade name Veraflox) is a 3rd generation enhanced spectrum veterinary antibiotic of the fluoroquinolone class. It was developed by Bayer HealthCare AG, Animal Health GmbH, and received approval from the European Commission in April 2011 for prescription-only use in veterinary medicine for the treatment of bacterial infections in dogs and cats. The primary mode of action of fluoroquinolones involves interaction with enzymes essential for major DNA functions such as replication, transcription, and recombination. The primary targets for Pradofloxacin are the bacterial DNA gyrase and topoisomerase IV enzymes. Reversible association between Pradofloxacin and DNA gyrase or DNA topoisomerase IV in the target bacteria results in inhibition of these enzymes and rapid death of the bacterial cell. The rapidity and extent of bacterial killing are directly proportional to the drug concentration.
Status:
Possibly Marketed Outside US
First approved in 2012
Source:
ANADA200304
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Copper naphthenate, a copper salt of naphthenic acid, is a wood preservative used for preservative treatment of wood poles, fence posts. This compound is not listed as a hazardous air pollutant or reproductive toxin.
Status:
Possibly Marketed Outside US
Source:
ZUPREVO by Merck
Source URL:
First approved in 2012
Source:
NADA141334
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Tildipirosin is a
semisynthetic derivative of the naturally occurring 16-membered macrolide tylosin. Tildipirosin is
intended for parenteral treatment of respiratory disease in cattle and swine. Tildipirosin will be
administered as a single-dose injection: subcutaneously in cattle and intramuscularly in swine. The
anticipated optimal clinical dose is 4 mg/kg bw.
Tildipirosin is not used in human medicine. It is marketed under the brand name Zuprevo. As for other macrolides, the antimicrobial activity of tildipirosin is due to its binding to the ribosomal
50S subunit of bacterial cells thereby inhibiting bacterial protein synthesis. The in vitro antimicrobial
activity against Gram-negative and Gram-positive pathogens indicates that tildipirosin is effective
against a range of bacterial pathogens frequently associated with bovine and swine respiratory
disease. Comparison of minimum inhibitory versus bactericidal concentrations shows that generally the
antimicrobial action of tildipirosin is bacteriostatic.