Eplerenone: Difference between revisions
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==History== | ==History== | ||
Inspra brand of eplerenone, submitted by GD Searle, was approved by the [[Food and Drug Administration]] in the [[United States]] with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) on September 27, 2002.<ref>{{FDA-Drug_Details|021437}}</ref> Generic versions with a AB [[Food and Drug Administration/Catalogs/Therapeutic Equivalence Code|Therapeutic Equivalence Code]] was approved with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ Abbreviated New Drug Application] (ANDA) on July 30, 2008<ref>{{FDA-Drug_Details|078482}}</ref> and August 1, 2008<ref>{{FDA-Drug_Details|078510}}</ref>. | Inspra brand of eplerenone, submitted by GD Searle, was approved by the [[Food and Drug Administration]] in the [[United States]] with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) on September 27, 2002.<ref>{{FDA-Drug_Details|021437}}</ref> Generic versions with a AB [[Food and Drug Administration/Catalogs/Therapeutic Equivalence Code|Therapeutic Equivalence Code]] was approved with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ Abbreviated New Drug Application] (ANDA) on July 30, 2008 (Apotex)<ref>{{FDA-Drug_Details|078482}}</ref> and August 1, 2008 (Sandoz)<ref>{{FDA-Drug_Details|078510}}</ref>. | ||
==Uses== | ==Uses== | ||
Revision as of 21:56, 20 February 2011
Eplerenone (e pler' en one) is an aldosterone receptor agonist, similar to spironolactone. Because it inhibits the negative regulatory feedback of aldosterone on renin secretion, increased plasma renin, and serum aldosterone, occur with its use. Eplerenone selectively binds to mineralocorticoid receptors relative to its binding to glucocorticoid, progesterone and androgen receptors.
History
Inspra brand of eplerenone, submitted by GD Searle, was approved by the Food and Drug Administration in the United States with a New Drug Application (NDA) on September 27, 2002.[1] Generic versions with a AB Therapeutic Equivalence Code was approved with a Abbreviated New Drug Application (ANDA) on July 30, 2008 (Apotex)[2] and August 1, 2008 (Sandoz)[3].
Uses
Eplerenone may help patients with mild[4] or moderate-to-severe[5] symptoms of heart failure.
External links
The most up-to-date information about Eplerenone and other drugs can be found at the following sites.
- Eplerenone - FDA approved drug information (drug label) from DailyMed (U.S. National Library of Medicine).
- Eplerenone - Drug information for consumers from MedlinePlus (U.S. National Library of Medicine).
- Eplerenone - Detailed information from DrugBank.
References
- ↑ Anonymous. Drugs@FDA for FDA Application No. 021437. U S Food and Drug Administration
- ↑ Anonymous. Drugs@FDA for FDA Application No. 078482. U S Food and Drug Administration
- ↑ Anonymous. Drugs@FDA for FDA Application No. 078510. U S Food and Drug Administration
- ↑ Zannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H et al. (2011). "Eplerenone in patients with systolic heart failure and mild symptoms.". N Engl J Med 364 (1): 11-21. DOI:10.1056/NEJMoa1009492. PMID 21073363. Research Blogging.
- ↑ Pitt B, Remme W, Zannad F, Neaton J, Martinez F, Roniker B et al. (2003). "Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction.". N Engl J Med 348 (14): 1309-21. DOI:10.1056/NEJMoa030207. PMID 12668699. Research Blogging. Review in: J Fam Pract. 2003 Aug;52(8):598-9 Review in: ACP J Club. 2003 Sep-Oct;139(2):32