Finasteride: Difference between revisions
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==History== | ==History== | ||
Proscar brand of finasteride 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) in 1992.<ref>[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchType=BasicSearch&Search_Button=Submit&searchTerm=020180 Drugs@FDA]. U S Food and Drug Administration</ref> A generic version 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) in 200_.<ref>[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchType=BasicSearch&Search_Button=Submit&searchTerm=076436 Drugs@FDA]. U S Food and Drug Administration</ref> | Proscar brand of finasteride was approved by the [[Food and Drug Administration]] in the [[United States of America]] with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) in 1992.<ref>[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchType=BasicSearch&Search_Button=Submit&searchTerm=020180 Drugs@FDA]. U S Food and Drug Administration</ref> A generic version 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) in 200_.<ref>[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchType=BasicSearch&Search_Button=Submit&searchTerm=076436 Drugs@FDA]. U S Food and Drug Administration</ref> | ||
==Pharmacology== | ==Pharmacology== | ||
Revision as of 12:22, 2 February 2023
In medicine, finasteride (Proscar®) is "an orally active testosterone 5-alpha-reductase inhibitor. It is used as a surgical alternative for treatment of benign prostatic hyperplasia."[1]
History
Proscar brand of finasteride was approved by the Food and Drug Administration in the United States of America with a New Drug Application (NDA) in 1992.[2] A generic version with a AB Therapeutic Equivalence Code was approved with a Abbreviated New Drug Application (ANDA) in 200_.[3]
Pharmacology
Administration
Distribution
Metabolism
Excretion
Toxicity
Drug toxicity includes
Uses
Benign prostatic hypertrophy
Prostate cancer prevention
Finasteride has also been found to reduce the incidence of prostate cancer in a randomized controlled trial; however, the trial reported statistical significance in the increase in the risk of high grade prostate cancer.[4] Subsequent analysis of the data suggests the incidence of high grade cancer is increased but without statistical significance.[5]
External links
The most up-to-date information about Finasteride and other drugs can be found at the following sites.
- Finasteride - FDA approved drug information (drug label) from DailyMed (U.S. National Library of Medicine).
- Finasteride - Drug information for consumers from MedlinePlus (U.S. National Library of Medicine).
- Finasteride - Detailed information from DrugBank.
References
- ↑ Anonymous (2024), Finasteride (English). Medical Subject Headings. U.S. National Library of Medicine.
- ↑ Drugs@FDA. U S Food and Drug Administration
- ↑ Drugs@FDA. U S Food and Drug Administration
- ↑ Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG et al. (2003). "The influence of finasteride on the development of prostate cancer.". N Engl J Med 349 (3): 215-24. DOI:10.1056/NEJMoa030660. PMID 12824459. Research Blogging. Review in: J Fam Pract. 2003 Nov;52(11):833, 837
- ↑ Redman MW, Tangen CM, Goodman PJ, Lucia MS, Coltman CA, Thompson IM (2008). "Finasteride does not increase the risk of high-grade prostate cancer: a bias-adjusted modeling approach.". Cancer Prev Res (Phila Pa) 1 (3): 174-81. DOI:10.1158/1940-6207.CAPR-08-0092. PMID 19138953. Research Blogging.