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Status:
US Previously Marketed
Source:
CYTELLIN by LILLY
(1961)
Source URL:
First approved in 1956
Class:
MIXTURE
Conditions:
Beta-sitosterol is one of the main dietary phytosterols found in plants which have a similar skeleton as cholesterol. In human clinical trials, beta-sitosterol has been shown to have cholesterol-lowering effects and to relieve symptoms of benign prostatic hyperplasia. There has been a large amount of basic research conducted for potential applications of beta-sitosterol in a diverse range of conditions including cervical cancer, breast cancer, cystic fibrosis, and others. Beta-sitosterol is available over the counter as a natural health supplement and is marketed for a wide range of applications including headaches, tuberculosis, allergies, cancers, fibromyalgia, lupus, asthma, hair loss and many others.
Status:
Possibly Marketed Outside US
Source:
NCT01284647: Phase 4 Interventional Completed Chronic Erosive Gastritis
(2011)
Source URL:
First approved in 2010
Source:
21 CFR 352
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Tetraprenylacetone (Geranylgeranylacetone) is an anti-peptic ulcer drug developed and approved in Japan in 1984. Tetraprenylacetone is shown to suppress H. pylori induced tissue and cell injury and inflammatory reaction, so it is expected to show beneficial effects on H. pylori-infected tissues. Tetraprenylacetone is used to treat patients suffering from peptic ulcers and gastritis. In Japan it is sold under the brand name Selbex.
Status:
Possibly Marketed Outside US
Source:
Maltos-10 by Otsuka [Japan]
Source URL:
First approved in 1995
Source:
BLA103649
Source URL:
Class:
MIXTURE
Maltose, a disaccharide, is found mainly in grains and cereals. Nutritionally, maltose provides the same number of calories as starches and other sugars. Maltose can be the agent responsible for the primary signals to induce the sensations of hunger and satiation in human beings. It was shown, that parenterally administered maltose could be of clinical value.
Status:
US Approved OTC
Source:
21 CFR 346.18(a) anorectal:astringent calamine
Source URL:
First marketed in 1921
Class:
PROTEIN
Targets:
Conditions:
There is no available information related any biological and pharmaceutical application of ammonium tetrachlorozincate.
Status:
US Previously Marketed
Source:
OMONTYS PRESERVATIVE FREE by TAKEDA PHARMS USA
(2012)
Source URL:
First approved in 2012
Source:
OMONTYS PRESERVATIVE FREE by TAKEDA PHARMS USA
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Peginesatide (trade name Omontys, formerly Hematide), developed by Affymax and Takeda, is an erythropoietic agent, a functional analog of erythropoietin. It was approved by the U.S. Food and Drug Administration for treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis. Peginesatide is a synthetic peptide, attached to polyethylene glycol ("PEGylated"). It mimics the structure of erythropoietin, the human glycoprotein which promotes red blood cell development. Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in vitro.
Status:
Possibly Marketed Outside US
First approved in 2014
Source:
21 CFR 352
Source URL:
Class:
PROTEIN
Targets:
Thymopentin is a synthetic pentapeptide which is the active site of the naturally occurring hormone thymopoietin with immunomodulating properties. Thymopentin can specifically promote the differentiation and maturation of thymic T cells and natural killer cells (NK) and enhance the function of T helper cells. thymic can achieve a two-way adjustment to the immune system by increasing the levels of intracellular cyclic adenosine monophosphate, elevating the activity of T cells, and regulating the proportions of T cell subsets. As an immunomodulating agent, Thymopentin is clinically used in the treatments of autoimmune diseases, such as e.g. atopic dermatitis, chronic lymphocytic leukemia, Sezary's syndrome, rheumatoid arthritis, as well as decreased immune competency in elder surgical patients. Due to poor membrane permeability, extensive metabolism in the GI, and extremely short half-life of 30 s, repeated injections or i.v infusions of Thymopentin are necessary which greatly restrict its clinical applications.
Status:
US Approved Rx
(2005)
Source:
NDA021660
(2005)
Source URL:
First approved in 1992
Source:
TAXOL by HQ SPCLT PHARMA
Source URL:
Class:
POLYMER
Targets:
Paclitaxel is a mitotic inhibitor used in cancer chemotherapy. It was discovered in a US National Cancer Institute program at the Research Triangle Institute in 1967 when Monroe E. Wall and Mansukh C. Wani isolated it from the bark of the Pacific yew tree, Taxus brevifolia and named it taxol. Later it was discovered that endophytic fungi in the bark synthesize paclitaxel. When it was developed commercially by Bristol-Myers Squibb (BMS), the generic name was changed to paclitaxel and the BMS compound is sold under the trademark Taxol. In this formulation, paclitaxel is dissolved in Kolliphor EL and ethanol, as a delivery agent. Taxol is marketed for the treatment of Breast cancer; Gastric cancer; Kaposi's sarcoma; Non-small cell lung cancer; Ovarian cancer. A newer formulation, in which paclitaxel is bound to albumin, is sold under the trademark Abraxane. Paclitaxel is a taxoid antineoplastic agent indicated as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary, and other various cancers including breast cancer. Paclitaxel is a novel antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. In addition, paclitaxel induces abnormal arrays or "bundles" of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis. Used in the treatment of Kaposi's sarcoma and cancer of the lung, ovarian, and breast. Abraxane® is specfically indicated for the treatment of metastatic breast cancer and locally advanced or metastatic non-small cell lung cancer. Paclitaxel interferes with the normal function of microtubule growth. Whereas drugs like colchicine cause the depolymerization of microtubules in vivo, paclitaxel arrests their function by having the opposite effect; it hyper-stabilizes their structure. This destroys the cell's ability to use its cytoskeleton in a flexible manner. Specifically, paclitaxel binds to the β subunit of tubulin. Tubulin is the "building block" of mictotubules, and the binding of paclitaxel locks these building blocks in place. The resulting microtubule/paclitaxel complex does not have the ability to disassemble. This adversely affects cell function because the shortening and lengthening of microtubules (termed dynamic instability) is necessary for their function as a transportation highway for the cell. Chromosomes, for example, rely upon this property of microtubules during mitosis. Further research has indicated that paclitaxel induces programmed cell death (apoptosis) in cancer cells by binding to an apoptosis stopping protein called Bcl-2 (B-cell leukemia 2) and thus arresting its function.
Status:
US Approved Rx
(2020)
Source:
ANDA212060
(2020)
Source URL:
First approved in 1939
Source:
LIQUAEMIN SODIUM by ASPEN GLOBAL INC
Source URL:
Class:
POLYMER
Нeparin (or Unfractionated heparin ) is an anticoagulant indicated for both the prevention and treatment of thrombotic events such as deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as atrial fibrillation (AF). Heparin can also be used to prevent excess coagulation during procedures such as cardiac surgery, extracorporeal circulation or dialysis, including continuous renal replacement therapy. Heparin administration can be by intravenous (or subcutaneous route. Intravenous heparin is continuously administered for therapeutic anticoagulation, while intermittent subcutaneous administration is used to prevent thromboembolism. Once administered, heparin binds reversibly to antithrombin III (ATIII) and greatly accelerates the rate at which ATIII inactivates coagulation enzymes thrombin (factor IIa) and factor Xa. The heparin-ATIII complex can also inactivate factors IX, XI, XII, and plasmin, but the antithrombotic effect of heparin is well correlated to the inhibition of factor Xa. Typical adverse effects from heparin use include bleeding, thrombocytopenia, injection site reactions, and other adverse effects only seen with chronic heparin administration. Bleeding is a major complication associated with heparin use. Patients should undergo monitoring for new bleeding that may present in the urine or stool. Bleeding may also present as bruising, petechial rash and nosebleeds.
Status:
US Approved Rx
(2020)
Source:
ANDA212060
(2020)
Source URL:
First approved in 1939
Source:
LIQUAEMIN SODIUM by ASPEN GLOBAL INC
Source URL:
Class:
POLYMER
Нeparin (or Unfractionated heparin ) is an anticoagulant indicated for both the prevention and treatment of thrombotic events such as deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as atrial fibrillation (AF). Heparin can also be used to prevent excess coagulation during procedures such as cardiac surgery, extracorporeal circulation or dialysis, including continuous renal replacement therapy. Heparin administration can be by intravenous (or subcutaneous route. Intravenous heparin is continuously administered for therapeutic anticoagulation, while intermittent subcutaneous administration is used to prevent thromboembolism. Once administered, heparin binds reversibly to antithrombin III (ATIII) and greatly accelerates the rate at which ATIII inactivates coagulation enzymes thrombin (factor IIa) and factor Xa. The heparin-ATIII complex can also inactivate factors IX, XI, XII, and plasmin, but the antithrombotic effect of heparin is well correlated to the inhibition of factor Xa. Typical adverse effects from heparin use include bleeding, thrombocytopenia, injection site reactions, and other adverse effects only seen with chronic heparin administration. Bleeding is a major complication associated with heparin use. Patients should undergo monitoring for new bleeding that may present in the urine or stool. Bleeding may also present as bruising, petechial rash and nosebleeds.
Status:
US Approved OTC
Source:
21 CFR 346.18(a) anorectal:astringent calamine
Source URL:
First marketed in 1921
Source:
Solution of Ferric Subsulphate U.S.P.
Source URL:
Class:
POLYMER
Conditions:
Ferric Ammonium EDTA Solution is normally used as a photographic chemical for a bleaching agent in the process of colour washing. It is also used as a complexing, and oxidizing agent & as a fertilizer and catalyst. EDTA acid are colourless, water-soluble solid that are widely used to dissolve scale. The usefulness of these ammonium salts arise because of its role as a chelating agent, i.e. its ability to "sequester" metal ions such as Ca2+ and Fe3+.