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Search results for "PART 522 IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS" in comments (approximate match)
Status:
Possibly Marketed Outside US
First approved in 2004
Source:
NADA141230
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Firocoxib is a selective COX-2 inhibitor which was approved by FDA and EMEA for the treatment of osteoarthritis and postoperative pain in dogs (Previcox trade name) and horses (Equioxx trade name). The drug is not for human use.
Status:
Possibly Marketed Outside US
Source:
Unknown
Source URL:
First approved in 2003
Source:
ANADA200308
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Flunixin meglumine is a potent, non-narcotic, non-steroidal, analgesic agent with anti-inflammatory and anti-pyretic activity was approved to use in horses, cattle and pigs. In horses it is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders. It is also recommended for the alleviation of visceral pain associated with colic. In the cattle: it is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. It is also indicated for the control of inflammation in endotoxemia. Flunixin persists in inflammatory tissues and is associated with anti-inflammatory properties which extend well beyond the period associated with detectable plasma drug concentration. Flunixin meglumine is classified as a carboxylic acid. Its mechanism of action is believed to be primarily via the inhibition of cyclooxygenase (COX) enzymes. This inhibition results in decreased formation of cyclooxygenase-derived eicosanoids involved in the pathophysiology of inflammation, such as thromboxanes and prostaglandins.
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:
NCT00159848: Phase 4 Interventional Completed Impotence
(2003)
Source URL:
First approved in 1997
Source:
NADA141084
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Lufenuron is used to fight fungal infections, since fungus cell walls are about one third chitin. Lufenuron is the active ingredient in the veterinary flea control medication Program. FDA approved this drug for use in dogs and cats. Available by prescription. Once the female flea ingests blood from a pet treated with lufenuron, 96% of egg development from fleas on cats and 99% of egg development from fleas on dogs is stopped. This helps prevent a continual flea problem. Lufenuron does not kill the adult flea and does not stop the flea from biting and causing flea allergy dermatitis. The drug is stored in the body fat and released into the bloodstream over the course of a month. Flea eggs laid prior to treating the pet may take several months to hatch; Program will not be effective until these fleas start to lay eggs. Therefore it may take several months to see the product's effectiveness. If quicker results are needed, use a product which will kill adult fleas; these will provide quicker relief for the pet. Cats require a higher dose per pound than dogs. After the cat injectable form is administered, 2-3 weeks are needed to reach therapeutic levels in the blood. The injectable form for cats is effective for 6 months.
Status:
Possibly Marketed Outside US
First approved in 1996
Source:
NADA141061
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Doramectin is a macrocyclic lactone isolated from fermentations of selected strains derived from the soil organism Streptomyces avermitilis. A primary mode of action of macrocyclic lactones is to modulate chloride ion channel activity in the nervous system of nematodes and arthropods. Macrocyclic lactones bind to receptors that increase membrane permeability to chloride ions. This inhibits the electrical activity of nerve cells in nematodes and muscle cells in arthropods and causes paralysis and death of the parasites. Doramectin is indicated for the treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and sucking lice, horn flies, and mange mites in cattle.
Status:
Possibly Marketed Outside US
First approved in 1996
Source:
Strovite Forte Caplet by Everett Laboratories, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Selenium (Se) is mineral that is found in soil and occurs naturally in certain foods (such as whole grains, Brazil nuts, sunflower seeds, and seafood). Selenium, which is nutritionally essential for humans, is a constituent of more than two dozen selenoproteins that play critical roles in reproduction, thyroid hormone metabolism, DNA synthesis, and protection from oxidative damage and infection. Selenium is used to treat or prevent selenium deficiency. Selenium deficiency produces biochemical changes that might predispose people who experience additional stresses to develop certain illnesses. For example, selenium deficiency in combination with a second stress (possibly a viral infection) leads to Keshan disease, a cardiomyopathy that occurred in parts of China prior to a government-sponsored selenium supplementation program that began in the 1970s. Before the Chinese government supplementation program, adults in the Keshan disease areas had average selenium intakes of no more than 11 mcg/day; intakes of at least 20 mcg/day protect adults from Keshan disease. Selenium has been used in alternative medicine as an aid to treat Hashimoto's thyroiditis, and to treat high cholesterol. Selenium is an important enzyme in the prevention of cellular damage by free radicals and reactive oxygen species. Selenium is first metabolized to selenophosphate and selenocysteine. Selenium incorporation is genetically encoded through the RNA sequence UGA. This sequence is recognized by RNA ste loop structures called selenocysteine inserting sequences (SECIS). These structures require the binding of SECIS binding proteins (SBP-2) to recognize selenocystiene. The specialized tRNA is first bound to a serine residue which is then enzymatically processed to a selylcysteyl-tRNA by selenocystiene sythase using selenophosphate as a selenium donor. Other unidentified proteins are required as part of the binding of this tRNA to the ribosome. Numerous studies in animal models and more recent studies in humans have demonstrated cancer chemopreventive effects with Se. There is extensive evidence that monomethylated forms of Se are critical metabolites for chemopreventive effects of Se. Induction of apoptosis in transformed cells is an important chemopreventive mechanism. Apoptosis can be triggered by micromolar levels of monomethylated forms of Se independent of DNA damage and in cells having a null p53 phenotype. Cell cycle protein kinase cdk2 and protein kinase C are strongly inhibited by various forms of Se. Inhibitory mechanisms involving modification of cysteine residues in proteins by Se have been proposed that involve formation of Se adducts of the selenotrisulfide (S-Se-S) or selenenylsulfide (S-Se) type or catalysis of disulfide formation. Selenium may facilitate reactions of protein cysteine residues by the transient formation of more reactive S-Se intermediates. A novel chemopreventive mechanism is proposed involving Se catalysis of reversible cysteine/disulfide transformations that occur in a number of redox-regulated proteins, including transcription factors. A time-limited activation mechanism for such proteins, with deactivation facilitated by Se, would allow normalization of critical cellular processes in the early stages of transformation. Randomized controlled trials of selenium supplementation for cancer prevention have yielded conflicting results. In 2003, the FDA allowed a qualified health claim on foods and dietary supplements containing selenium to state that while “some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer… FDA has determined that this evidence is limited and not conclusive”. Selenium is available in multivitamin/multimineral supplements and as a stand-alone supplement, often in the forms of selenomethionine or of selenium-enriched yeast (grown in a high-selenium medium) or as sodium selenite or sodium selenate.
Status:
Possibly Marketed Outside US
First approved in 1996
Source:
NADA141063
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Florfenicol (Nuflor) is a fluorinated synthetic analog of thiamphenicol. Florfenicol is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia (Pasteurella) haemolytica, Pasteurella multocida, and Haemophilus somnus, for treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. Florfenicol is a broad-spectrum, primarily bacteriostatic, antibiotic with a range of activity similar to that of chloramphenicol, including many gram-negative and gram-positive organisms; however, florfenicol does not carry the risk of inducing human aplastic anemia that is associated with chloramphenicol. It also has activity against some chloramphenicol resistant strains of bacteria, possibly because it is less affected by the major enzyme produced in plasmid-mediated bacterial resistance against chloramphenicol and thiamphenicol. Although the activity of florfenicol against obligate anaerobes is not addressed in the literature, it is likely to be quite effective. Antibiotic principle of Florfenicol is similar to that of chloramphenicol and Thiamphenicol. Florfenicol inhibits protein synthesis by binding to 70S ribosomal 50S subunits of susceptible bacteria, leading to the inhibition of peptidyl transferase and thereby preventing the transfer of amino acids to extending peptide chains and subsequent protein formation. The bacterial receptor that is the site of action for florfenicol is also considered to be the same as that for chloramphenicol and thiamphenicol. Florfenicol has a fluorine atom instead of the hydroxyl group located at C-3 in the structure of chloramphenicol and thiamphenicol. This prevents the acetylation of bacterial acetyltransferase in this site as to allow florfenicol to be less susceptible to deactivation by bacteria with plasmid-transmissible resistance that involves acetylation of the C-3 hydroxyl group in chloramphenicol and thiamphenicol, and prevents their interaction with bacterial ribosomes.
Status:
Possibly Marketed Outside US
First approved in 1990
Source:
NADA140833
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Clorsulon is a compound belonging to the benzenesulphonamide family. It is used in veterinary medicine for the treatment of liver fluke (monotherapy), gasrtointestinal and lung worms, lice, grubs and mites (in combination with ivermectin) in cattles. Clorsulon inhibits the enzymes involved in the glycolytic pathways of the common liver fluke (Fasciola hepatica or Fasciola gigantica), namely phosphoglycerate kinase and phosphoglyceromutase.
Status:
Possibly Marketed Outside US
Source:
NAXCEL Sterile Powder by Yancey, R.J. et al.
Source URL:
First approved in 1988
Source:
NADA140338
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Ceftiofur is an antibiotic of the cephalosporin type (third generation), licensed for use in veterinary medicine only. It was first described in 1987. It is marketed by pharmaceutical company Zoetis as Excenel, Naxcel, and Excede and is also the active ingredient in that company's Spectramast LC (lactating cow formulation) and Spectramast DC (dry cow formulation) product. Ceftiofur has worldwide approvals for respiratory disease in swine, ruminants (cattle, sheep and goats) and horses and has also been approved for foot rot and metritis infections in cattle. Ceftiofur has also been approved in various countries for early mortality infections in day-old chicks and turkey poults. Ceftiofur (NAXCEL) is indicated for treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. NAXCEL is also indicated for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Status:
Possibly Marketed Outside US
First approved in 1988
Source:
NADA140441
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Enrofloxacin was developed by Bayer for the treatment of broad spectrum of bacterial infections in animals (cats and dogs). The drug exerts its action by inhibiting DNA Topoisomerase II (Gyrase) and DNA Topoisomerase IV (Topo IV), two major bacterial topoisomerase. Enrofloxacin was shown to be metabolized to ciprofloxacin and may cross the blood brain barrier in the animals.