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Status:
US Approved Rx
(2016)
Source:
NDA208114
(2016)
Source URL:
First approved in 2016
Source:
NDA208114
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(2015)
Source:
NDA205739
(2015)
Source URL:
First approved in 2015
Source:
NDA205739
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(2015)
Source:
NDA205739
(2015)
Source URL:
First approved in 2015
Source:
NDA205739
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(2013)
Source:
NDA205098
(2013)
Source URL:
First approved in 2010
Source:
NDA021201
Source URL:
Class:
POLYMER
Targets:
Conditions:
Polidocanol is a non-ionic surfactant sclerosing agent indicated to treat uncomplicated spider veins and uncomplicated reticular veins in the lower extremity. Polidocanol also is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee. When administered, polidocanol locally damages blood vessel endothelium. Following the endothelial damage, platelets aggregate at the site and attach to the venous wall eventually resulting in a dense network of platelets, cellular debris, and fibrin that occludes the vessel. Eventually the vessel is replaced by connective fibrous tissue. Adverse reactions include pain in extremity, infusion site thrombosis, contusion/injection site hematoma, limb discomfort and some others.
Status:
US Approved Rx
(2019)
Source:
ANDA208670
(2019)
Source URL:
First approved in 2000
Source:
WELCHOL by COSETTE
Source URL:
Class:
POLYMER
Targets:
Colesevelam (trade name Welchol) a non-absorbed, polymeric, lipid-lowering agent intended for oral administration. Colesevelam is poly(allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. Colesevelam hydrochloride is a hydrophilic, water-insoluble polymer that is not hydrolyzed by digestive enzymes and is not absorbed. Colesevelam is part of a class of drugs known as bile acid sequestrants. Colesevelam hydrochloride, the active pharmaceutical ingredient in Welchol, is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption. As the bile acid pool becomes depleted, the hepatic enzyme, cholesterol 7-α-hydroxylase, is upregulated, which increases the conversion of cholesterol to bile acids. This causes an increased demand for cholesterol in the liver cells, resulting in the dual effect of increasing transcription and activity of the cholesterol biosynthetic enzyme, HMG-CoA reductase, and increasing the number of hepatic LDL receptors. These compensatory effects result in increased clearance of LDL-C from the blood, resulting in decreased serum LDL-C levels. Colesevelam is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia as monotherapy and to improve glycemic control in adults with type 2 diabetes mellitus, including in combination with a statin. The expanded use of colesevelam in adults with type 2 diabetes mellitus is an example of drug repositioning.
Status:
US Approved Rx
(2007)
Source:
ANDA065361
(2007)
Source URL:
First approved in 1999
Source:
NDA050778
Source URL:
Class:
POLYMER
Targets:
Conditions:
Epirubicin is an anthracycline cytotoxic agent, is a 4'-epi-isomer of doxorubicin. The compound is marketed by Pfizer under the trade name Ellence in the US. It is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. Although it is known that anthracyclines can interfere with a number of biochemical and biological functions within eukaryotic cells, the precise mechanisms of epirubicin’s cytotoxic and/or antiproliferative properties have not been completely elucidated. It is known, that epirubicin forms a complex with DNA by intercalation of its planar rings between nucleotide base pairs, with consequent inhibition of nucleic acid (DNA and RNA) and protein synthesis. Such intercalation triggers DNA cleavage by topoisomerase II, resulting in cytocidal activity. Epirubicin also inhibits DNA helicase activity, preventing the enzymatic separation of double-stranded DNA and interfering with replication and transcription. Epirubicin is also involved in oxidation/reduction reactions by generating cytotoxic free radicals.
Status:
US Approved Rx
(2023)
Source:
ANDA206100
(2023)
Source URL:
First approved in 1998
Source:
RENAGEL by GENZYME
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(2023)
Source:
ANDA206100
(2023)
Source URL:
First approved in 1998
Source:
RENAGEL by GENZYME
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(1996)
Source:
NDA020193
(1996)
Source URL:
First approved in 1996
Source:
NDA020193
Source URL:
Class:
POLYMER
Conditions:
Pentosan polysulfate sodium (brand name ELMIRON) is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects and is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. The mechanism of action of pentosan polysulfate sodium in interstitial cystitis is not known but was discovered, that it t binds Fibroblast growth factors (FGFs) as well as other heparin-binding growth factors.
Status:
US Approved Rx
(2017)
Source:
ANDA206936
(2017)
Source URL:
First approved in 1996
Source:
NDA020622
Source URL:
Class:
POLYMER