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Restrict the search for
ixazomib citrate
to a specific field?
Status:
US Approved Allergenic Extract
(1994)
Source:
BLA103738
(1994)
Source URL:
First approved in 1994
Source:
BLA103738
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Methyldibromo glutaronitrile (MDBGN) is a bromine-containing preservative that has been used in cosmetic and toiletry preparations as well as in some industrial products. A maximum concentration of 0.1% MDBGN in stay-on and rinse-off cosmetics was approved for use in the mid 1980’s and animal tests showed it to be a weak sensitiser compared to other preservatives used at the time. By the 1990’s it became a commonly used preservative, particularly in cosmetic and self-hygiene products.
However, methyldibromo glutaronitrile was soon discovered to cause allergic contact dermatitis reactions in eczema patients. Rates of sensitisation to MDBGN increased from 0.7% in 1991 to 3.5% in 2000 in patch test studies from 16 European centres. In the United States, sensitivity rates were up to 11.7%. In 2005, the European Union, banned the use of MDBGN in stay-on products, and then later in 2007 also in rinse-off products. Recent data from Europe observed a significant decrease in positive patch test reactions since the ban of MDBGN.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(20) weight control choline
Source URL:
First approved in 2001
Source:
Vitamin B Complex 150 by Covetrus North America
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
CHOLINE is a basic constituent of lecithin that is found in many plants and animal organs. Choline was officially recognized as an essential nutrient by the Institute of Medicine in 1998.1 Its role in the body is complex. It is needed for neurotransmitter synthesis (acetylcholine), cell-membrane signaling (phospholipids), lipid transport (lipoproteins), and methyl-group metabolism (homocysteine reduction). It is the major dietary source of methyl groups via the synthesis of S-adenosylmethionine (AdoMet). At least 50 AdoMet-dependent reactions have been identified in mammals, and it is likely that the number is much higher. Choline is required to make the phospholipids phosphatidylcholine, lysophosphatidylcholine, choline plasmalogen, and sphingomyelin—essential components for all membranes. It plays important roles in brain and memory development in the fetus and appears to decrease the risk of the development of neural tube defects. The importance of choline in the diet extends into adulthood and old age. In a study of healthy adult subjects deprived of dietary choline, 77% of the men and 80% of the postmenopausal women developed signs of subclinical organ dysfunction (fatty liver or muscle damage). Less than half of premenopausal women developed such signs. Ten percent of the subjects studied developed fatty liver, muscle damage, or both when they consumed the Adequate Intake (AI) of choline. The damage was reversed when they consumed a high-choline diet. Plasma choline concentration has been found to vary in response to diet, decreasing approximately 30 percent in humans fed a choline-deficient diet for 3 weeks. Based on estimated dietary intakes and studies reporting liver damage with lower choline intakes, the Institute of Medicine, Food and Nutrition Board set the AI for choline at 425 milligrams/per day for women aged 19 and older, and 550 milligrams/per day for men aged 19 and older.
Status:
US Previously Marketed
Source:
GANITE by CHAPTER 7 TRUSTEE
(1991)
Source URL:
First approved in 1991
Source:
GANITE by CHAPTER 7 TRUSTEE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Gallium nitrate (brand name Ganite) is a drug that is used to treat hyper-calcemia, or too much calcium in the blood. Ganite exerts a hypocalcemic effect by inhibiting calcium resorption from bone, possibly by reducing increased bone turnover. It was shown, that gallium favorably altered the mineral properties to enhance hydroxyapatite crystallization and reduced mineral solubility. The drug also acted on the cellular components of bone to reduce bone resorption by decreasing acid secretion by osteoclasts. Nevertheless, ganite was withdrawn from sale, although the reasons was not the safety or effectiveness. Gallium nitrate inhibits the growth of various lymphoma cell lines in vitro and exhibits antitumor activity in patients with lymphoma. Gallium binds avidly to the iron transport protein transferrin. Transferrin-gallium complexes preferentially target cells that express transferrin receptors on their surface. Expression of transferrin receptors is particularly high on lymphoma cells. Cellular uptake of the gallium-transferrin complex leads to inhibition of cellular proliferation primarily via disruption of iron transport and homeostasis and blockade of ribonucleotide reductase. In phase II of clinical trials in patients with relapsed or refractory lymphoma, the antitumor activity of gallium nitrate is similar to, or better than, that of other commonly used chemotherapeutic agents.
Status:
US Previously Marketed
Source:
FERROUS CITRATE FE 59 by MALLINCKRODT
(1973)
Source URL:
First approved in 1973
Source:
FERROUS CITRATE FE 59 by MALLINCKRODT
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Ferrous citrate Fe 59 is indicated, by intravenous administration, to determine various parameters of the kinetics of iron metabolism, including plasma iron clearance, plasma iron turnover rate, and the utilization of iron in new red blood cells. The values of serum iron obtained from these studies provide diagnostic information in patients with anemias. Ferrous citrate Fe 59 is also useful to assess the role of the spleen in red blood cell production and destruction, and thus to help determine the advisability of splenectomy. Also, organ uptake measurements are used to measure the sites of red cell production (or lack thereof) in extramedullary erythropoiesis in myeloproliferative disorders. Iron from ferrous citrate is bound to plasma protein (transferrin) and carried to the blood-forming organs where it is utilized to form hemoglobin or is deposited in the reticuloendothelial cells of the liver and spleen. The amount of radioactive iron absorbed, transported, stored, utilized, and excreted can then be measured by the periodic collection of blood specimens and external counting.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(20) weight control lysine hydrochloride
Source URL:
First approved in 1971
Source:
NDA016822
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Lysing is an essential basic amino-acid encoded by codone AAA and AAG, and used in the biosynthesis of proteins. The daily requirement for lysine is 38 mg/kg body weight. The most rich source of lysine is fish, beef, chicken. In a clinical study lysine supplements was found to be an effective for reduction of occurrence, severity and healing time for recurrent HSV infection, however Cochrane Review concluded that the evidence is insufficient. Lysine was investigated for improving anxiety, ameliorating angina prectoris. Lysine acetylsalicylate has been used to treat pain and to detoxify the body after heroin use. Lysine clonixinate has been used for its analgesic properties for the treatment of migraine headaches and other painful conditions. However, limited clinical trials exist for these conditions.
Status:
US Previously Marketed
Source:
MINTEZOL by MERCK SHARP DOHME
(1967)
Source URL:
First approved in 1967
Source:
MINTEZOL by MERCK SHARP DOHME
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Thiabendazole (TBZ, trade names Mintezol, Tresaderm, and Arbotect) was first introduced in 1962. This drug is a fungicide and parasiticide and is indicated for the treatment of: strongyloidiasis (threadworm), cutaneous larva migrans (creeping eruption), visceral larva migrans, trichinosis: relief of symptoms and fever and a reduction of eosinophilia have followed the use of this drug during the invasion stage of the disease. But usage of this drug was discontinued. The precise mode of action of thiabendazole on the parasite is unknown, but it may inhibit the helminthspecific enzyme fumarate reductase. It was shown, also that thiabendazole reversibly disassembles newly established blood vessels, marking it as vascular disrupting agent (VDA) and thus as a potential complementary therapeutic for use in combination with current anti-angiogenic therapies. Was shown, that vascular disruption by TBZ results from reduced tubulin levels and hyper-active Rho signaling. In addition, was confirmed, that thiabendazole slowed tumor growth and decreased vascular density in preclinical fibrosarcoma xenografts and thus, it could lead directly to the identification of a potential new therapeutic application for an inexpensive drug that is already approved for clinical use in humans.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(22)(ii) antifungal:diaper rash benzoxiquine
Source URL:
First approved in 1964
Source:
UDDER BALM by H. W. Naylor Company Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
In cosmetics and personal care products, Benzoxiquine has been reported to be used in the formulation of hair tonics, dressings, and other hair grooming aids. Benzoxiquine is described as a biocide for use in cosmetic products. It is currently reported to be used in only one product. In a separate finding, the Food and Drug Administration determined that Benzoxiquine is not generally recognized as safe and effective in over-the-counter topical antifungal drug products. The only data available on the toxicity of Benzoxiquine indicates that it is mutagenic in the Ames test without metabolic activation. Because of the lack of data, the safety of Benzoxiquine could not be substantiated. The data needed to make a safety assessment include purity/impurities, ultraviolet absorption (if there is absorption, then photosensitization data will be needed), 28-day dermal toxicity, dermal teratogenicity, ocular irritation (if already available only), dermal irritation and sensitization, and two different genotoxicity studies (one using a mammalian system). If the latter data are positive, dermal carcinogenesis data using the methods of the National Toxicology Program will be needed. It cannot be concluded that Benzoxiquine is safe for use in cosmetic products until these safety data have been obtained and evaluated.
Status:
US Previously Marketed
Source:
TARACTAN by ROCHE
(1962)
Source URL:
First approved in 1962
Source:
TARACTAN by ROCHE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Chlorprothixene (Taractan, Tarasan, Truxal) is a thioxanthine derivative developed by Lundbeck for the treatment of psychotic disorders. The drug exerts its activity by binding to and inhibiting serotonin receptors, dopamine receptors, muscarinic acetylcholine receptor, histamine H1 receptor and alpha1-adrenergic receptor.
Status:
First approved in 1957
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Triacetin, also known as Glyceryl Triacetate, is a cosmetic biocide, plasticizer, and solvent in cosmetic formulations, at concentrations ranging from 0.8% to 4.0%. It is a commonly used carrier for flavors and fragrances. Triacetin was affirmed as a generally recognized as safe (GRAS) human food ingredient by the Food and Drug Administration (FDA). It is used as an inactive ingredient additive in some drug formulations. It has been used as a plasticizer in the tests of acrylic polymer films for drug delivery. Triacetin is not toxic to animals. However, in one study, it caused erythema, slight edema, alopecia, and desquamation, and did cause some irritation in rabbit eyes. Concentration of triacetin in consumer products is in the range of about 0.005-2 % for cosmetics, and has been reported to be as high as 15-33 % for one specific antifungal drug.
