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Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2009
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
First approved in 2009
Source:
IQQU Acne Serum by IQQU USA Co.
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
L-carnitine (L-beta-hydroxy-gamma-N,N,N-trimethylaminobutyric acid) is conditionally necessary for mitochondrial transport and metabolism of long-chain fatty acids, and thus for myocardial energetic metabolism. D-carnitine is not biologically active and might interfere with proper utilization of the L isomer, and so there are claims that the racemic mixture (DL-carnitine) should be avoided. The pharmacological effects of carnitine are stereospecific: L-carnitine was effective in various animal and clinical studies, while D- and DL-carnitine was found to be ineffective or even toxic to some cells and tissues, such as muscle cells and the myocardium. DL-carnitine caused symptoms of myasthenia and cardiac arrhythmias, which disappeared after L-carnitine administration.
Status:
Possibly Marketed Outside US
Source:
NADA141025
(2009)
Source URL:
First approved in 2009
Source:
NADA141025
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Laidlomycin is a polycyclic polyether antibiotic which possesses an inhibitory activity against various mycoplasma species}, and is effective in controlling coccidiosis in chickens. It is also known as selectively inhibiting the
migration of hemagglutinin glycoprotein from Golgi apparatus to the cell surface in measles virus). Laidlomycin inhibited growth of some Gram-positive bacteria only at high concentrations such as 50-100 ug/ml,
but was not active against Gram-negative bacteria,
yeast and fungi even at concentration of 1,000 ug/ml. In broth dilution, laidlomycin was active against several illycoplasmas and most active against the sterol-nonrequiring mycoplasma, Acholeplasma laidlawii. Under the brand name Cattlyst Laidlomycin is indicated for improved feed efficiency and increased rate of weight gain in cattle fed in confinement for slaughter.
Status:
Possibly Marketed Outside US
First approved in 2009
Source:
ANADA200075
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Salinomycin Sodium is active against certain Gram-positive bacteria, while Gram-negative species are resistant. The use of Salinomycin Sodium as a feed additive at the proposed concentration is unlikely to increase shedding of Salmonella, Escherichia coli, and Campylobacter or to induce resistance and cross-resistance to antimicrobials important in human and animal therapy. Salinomycin Sodium is safe for chickens for fattening at a concentration of 70 mg/kg complete feed with a margin of safety of 1.7. For chickens reared for laying, 50 mg Salinomycin Sodium /kg complete feed is considered safe for a feeding period of the first 12 weeks of life; a margin of safety cannot be given. The simultaneous use of Salinomycin Sodium and certain antibiotic drugs (e.g. tiamulin) is contraindicated. Salinomycin Sodium is absorbed to a certain extent in the chicken and extensively metabolized. Unchanged Salinomycin Sodium represents a very small fraction of the metabolites in tissue and excreta. Many metabolites, predominantly mono- and multi-hydroxylated, have been identified in tissues and excreta. The metabolites in excreta showed a higher degree of hydroxylation than in the liver. Salinomycin -related metabolites have a reduced ionophoric activity when compared with Salinomycin. Salinomycin is considered the MR; ratios of MR to total residue are available for all relevant tissues for 1 and 6 h withdrawal. No residues eggs are expected provided that the proposed maximum dose and duration of administration are respected.
Status:
Possibly Marketed Outside US
Source:
NADA141295
(2009)
Source URL:
First approved in 2009
Source:
NADA141295
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Toceranib (toceranib phosphate) is an orally bioavailable small molecule inhibitor that blocks a variety of RTKs, including VEGFR2, PDGFRa and KIT. In non-clinical pharmacology studies, toceranib selectively inhibited the tyrosine kinase activity of several members of the split kinase receptor tyrosine kinase (RTK) family, some of which are implicated in tumor growth, pathologic angiogenesis, and metastatic progression of cancer. Toceranib inhibited the activity of Flk-1/KDR tyrosine kinase (vascular endothelial growth factor receptor, VEGFR2), platelet-derived growth factor receptor (PDGFR), and stem cell factor receptor (Kit) in both biochemical and cellular assays. Toceranib has been shown to exert an antiproliferative effect on endothelial cells in vitro. Toceranib treatment can induce cell cycle arrest and subsequent apoptosis in tumor cell lines expressing activating mutations in the split kinase RTK, ckit. Canine mast cell tumor growth is frequently driven by activating mutations in c-kit. Toceranib is a dog-specific anti-cancer drug approved by the U.S. Food and Drug Administration. It is marketed as Palladia as its phosphate salt, toceranib phosphate by Pfizer. PALLADIA (Toceranib) tablets are indicated for the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs.
Status:
Possibly Marketed Outside US
First approved in 2009
Source:
NADA048486
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Robenidine (l,3-6ts (p-chlorobenzylidenamino) guanidine hydrochloride) is
an effective anticoccidial, first introduced by Kantor, Kennett, Waletzky &
Tomcufcik (1970). It does not affect the earliest stages in the coccidial life-cycle and
its main activity is against the almost mature first generation schizont. It is used as an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima and E. necatrix in broiler chickens.
Status:
Possibly Marketed Outside US
First approved in 2009
Source:
NADA096298
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Lasalocid is a polyether ionophore with potent antibacterial activity. Lasalocid was developed as an animal health product for treatment of coccidia. Lasalocid is able to form neutral complexes with monovalent and divalent cations and transport the ions through apolar phase (including lipid bilayer membranes). Interestingly, lasalocid can also transport larger organic cations, e.g. protonated dopamine. Lasalocid is used for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix,
E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate
of weight gain and improved feed efficiency in broiler chickens. Also used for control of coccidiosis caused by Eimeria bovis and E. zuernii in cattle up to 800 lbs. and for prevention of coccidiosis caused by Eimeria ovina, E. crandallis, E. ovinoidalis (E. ninakohlyakimovae), E. parva and E. intricata in sheep maintained in confinement. Lasalocid has being shown to induce cytotoxic apoptosis and cytoprotective autophagy through reactive oxygen species in human prostate cancer PC-3 cells. Lasalocid should be useful in the search for new potential chemotherapeutic agents for understanding the molecular mechanisms of anticancer in prostate cancer cells.
Status:
Possibly Marketed Outside US
Source:
Prenatvite by SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
Source URL:
First approved in 2009
Source:
Calcium Folic Acid Plus D Chewable by Acella Pharmaceuticals, LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Boron gluconate is a boron-containing dietary supplement. Calcium salt of boron gluconate is used as a calcium supplement in veterinary to treat hypocalcemia (also called parturient paresis and commonly called milk fever) in cattle, sheep, and goat.
Status:
Possibly Marketed Outside US
Source:
M020
(2023)
Source URL:
First approved in 2009
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 347
(2010)
Source URL:
First approved in 2009
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
The oil obtained from the seeds of the castor oil plant Ricinus communis is one of the oldest drugs known to man. Castor oil is known primarily as an effective laxative; however, it was also used in ancient times with pregnant women to induce labor. Aside from getting rid of acne, castor oil also helps detoxify the skin. It helps break up the oils that clog glands and pores on the face. Only now, have scientists at the Max Planck Institute for Heart and Lung Research succeeded in unravelling the mysteries of the action mechanism. Ricinoleic acid released from the oil in the intestine, is responsible for the analgesic and anti-inflammatory effects. It was discovered, that G protein-coupled receptors, a large group of receptors in the body involved primarily in transmitting signals in cells. Hundreds of receptors were systematically turned off, and then the reaction of the cells to ricinoleic acid was tested. Ultimately, was succeeded identified the key receptor with the name EP3. There was concluded that after being released from the castor oil, the ricinoleic acid is first of all absorbed by the body via the intestinal mucosa; the EP3 receptor then becomes active on the muscle cells of the intestine and uterus, which in turn stimulates intestinal activity.