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Status:
US Approved Rx
(2020)
Source:
NDA208171
(2020)
Source URL:
First approved in 2020
Source:
NDA208171
Source URL:
Class:
POLYMER
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
(2013)
Source:
NDA202207
(2013)
Source URL:
First approved in 2013
Source:
NDA202207
Source URL:
Class:
POLYMER
Targets:
Technetium (99mTc) tilmanocept, trade name Lymphoseek, is a radiopharmaceutical diagnostic imaging agent approved for the imaging of lymph nodes. It is used to locate those lymph nodes which may be draining from tumors, and assist doctors in locating those lymph nodes for removal during surgery.
Status:
US Approved Rx
(2012)
Source:
NDA202292
(2012)
Source URL:
First approved in 2012
Source:
NDA202292
Source URL:
Class:
POLYMER
Conditions:
Crofelemer, previously known as the investigational drug SP-303, is a novel proanthocyanidin purified from the bark latex of the Amazonian Croton tree Croton lechleri. It is marketed under the brand name Fulyzaq and indicated for the symptomatic treatment of non-infectious diarrhea in adult patients with HIV/AIDS who are taking antiretroviral therapy. Fulyzaq treats the symptoms of disease, but it is not used to treat infectious diarrhea (diarrhea caused by infection of the digestive system by a bacteria, virus or parasite). It was initially developed by Napo Pharmaceuticals, which licensed it to Glenmark Pharmaceuticals in 140 emerging markets and to Salix Pharmaceuticals in the US, EU and some other markets. A Phase III clinical trial for diarrhoea in HIV patients was completed in 2012, and the drug was approved by the US Food and Drug Administration (FDA) on 31 December 2012.
Status:
US Approved Rx
(2023)
Source:
ANDA212886
(2023)
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
(2018)
Source:
ANDA210464
(2018)
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:
ANDA091646
(2017)
Source URL:
First approved in 1996
Source:
NDA020622
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(2003)
Source:
NDA021525
(2003)
Source URL:
First approved in 1995
Source:
NDA020451
Source URL:
Class:
POLYMER
Targets:
Conditions:
Porfimer is a photosensitizing agent used in the photodynamic therapy (PDT) of tumors. Porfimer sodium was approved under the brand name PHOTOFRIN for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy. For the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC). For the treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated. In addition, for the ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy. The cytotoxic and antitumor actions of PHOTOFRIN® are light and oxygen dependent. Photodynamic therapy with Porfimer sodium is a two-stage process. The first stage is the intravenous injection of the drug, which mainly is concentrated in the tumor tissues for a longer period. Illumination with 630 nm wavelength laser light constitutes the second stage of therapy. Cellular damage is a consequence of the propagation of radical reactions. Radical initiation may occur after porfimer absorbs light to form a porphyrin excited state. Tumor death also occurs through ischemic necrosis secondary to vascular occlusion that appears to be partly mediated by thromboxane A2 release. The laser treatment induces a photochemical, not a thermal, effect. The necrotic reaction and associated inflammatory responses may evolve over several days.