Warning Letter Elmiron
submission consisting of promotional launch materials for Elmiron (pentosan ... Elmiron for unapproved uses. Specifically, prescribers are instructed to " ...
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulat...
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Abstract for Repro Tox: Elmiron - National Toxicology Program
13 Sep 2007 ... The potential reproductive toxicity of Elmiron (sodium pentosan polysulfate) in Sprague-Dawley rats was evaluated using the Reproductive ...
http://ntp.niehs.nih.gov/?objectid=071D8855-D1CA-14A4-852C64...
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Analysis of long-term Elmiron therapy for interstitial cystitis.
OBJECTIVES: The long-term efficacy and safety of Elmiron (oral pentosan polysulfate sodium) in relieving recurring symptoms of interstitial cystitis (IC
) ...
http://www.ncbi.nlm.nih.gov/pubmed/9146008...
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The Interstitial Cystitis Clinical Trials Group, Randomized ...
25 Nov 2008 ... Elmiron® is the only oral drug approved by the Food and Drug Administration ... Elmiron® alone helped 28 percent of patients in the trial, ...
http://www2.niddk.nih.gov/AboutNIDDK/Organization/Divisions/...
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NTP technical report on the toxicology and carcinogenesis studies ...
The United States Food and Drug Administration nominated Elmiron for .... GENETIC TOXICOLOGY: Elmiron was not mutagenic in S. typhimurium strains TA97,
...
http://www.ncbi.nlm.nih.gov/pubmed/15213766...
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Testing Status: Elmiron (sodium pentosanpolysulfate) M882471 ...
Toxicology and Carcinogenesis Studies of Elmiron® (CAS No. ... Citation: Final Report on the Reproductive Toxicity of Elmiron Administered by Gavage to ...
http://ntp.niehs.nih.gov/go/TS-M882471...
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Toxicity and carcinogenicity of Elmiron in F344/N rats and B6C3F1 ...
Elmiron (sodium pentosan polysulfate) is used for the relief of urinary bladder pain associated with interstitial cystitis. The National Toxicology Program ...
http://www.ncbi.nlm.nih.gov/pubmed/14508637...
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elmiron (pentosan polysulfate sodium) capsule [ORTHO-McNEIL ...
ELMIRON® is supplied in white opaque hard gelatin capsules containing 100 mg pentosan polysulfate sodium, microcrystalline cellulose, and magnesium stearate
...
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=8130...
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Lysosomal-storage disorder induced by elmiron following 90-days ...
Elmiron, a highly sulfated, semisynthetic pentose polysaccharide with properties similar to heparin, is used for the treatment of interstitial cystitis. ...
http://www.ncbi.nlm.nih.gov/pubmed/11950161...
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Pentosan polysulfate - Wikipedia, the free encyclopedia
20 Aug 2009 ... Pentosan polysulfate (sold under the name Elmiron by Ortho-McNeil Pharmaceutical , inc.) was the first oral medication approved by the U.S. ...
http://en.wikipedia.org/wiki/Pentosan_polysulfate...
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