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<!-- History, society, and culture -->
Oxandrolone was first described in 1962 and introduced for medical use in 1964.<ref name="Llewellyn2011" /> The drug was a [[controlled substance]] in many countries, so non-medical use for purposes such as [[performance-enhancing substance|improving physique and performance]] it has been generally illicit.<ref name="Llewellyn2011" /><ref name="pmid9414081">{{cite journal | vauthors = Korkia P, Stimson GV | title = Indications of prevalence, practice and effects of anabolic steroid use in Great Britain | journal = International Journal of Sports Medicine | volume = 18 | issue = 7 | pages = 557–562 | date = October 1997 | pmid = 9414081 | doi = 10.1055/s-2007-972681 | s2cid = 260169851 | quote = Low dose 28 +/- 18; High dose 80 +/- 13 }}</ref><ref name="FDA2009" /><ref name="CanadaLaws" /><ref name="GovUK
In the United States, the [[FDA]]'s Endocrinologic and Metabolic Drugs Advisory Committee unanimously concluded in 1984 that there was no evidence of efficacy for oxandrolone.<ref name="OxandroloneFDAwithdrawal">{{cite web |title=Gemini Laboratories, LLC, et al.; Withdrawal of Approval of One New Drug Application for OXANDRIN (Oxandrolone) Tablets and Four Abbreviated New Drug Applications for Oxandrolone Tablets |url=https://www.federalregister.gov/documents/2023/06/28/2023-13733/gemini-laboratories-llc-et-al-withdrawal-of-approval-of-one-new-drug-application-for-oxandrin |website=[[Federal Register]] |publisher=[[Office of the Federal Register]] of the [[National Archives and Records Administration]] |access-date=1 January 2025}}</ref> On March 26, 2019, Gemini asked FDA to withdraw approval for all doses of the drug, stating that they were no longer marketing it.<ref name="fda923" /><ref name="OxandroloneFDAwithdrawal"/> FDA notified Gemini and other license holders on December 16, 2022, that it believed that the potential problems with the drug that the drug were sufficiently serious that it should be removed from the market, citing the 1984 finding of lack of efficacy and the extensive safety warnings and precautions listed on the [[drug label]], "including [[peliosis hepatis]], sometimes associated with [[liver failure]] and [[intra-abdominal hemorrhage]]; [[Liver tumor#Hepatic adenoma|liver cell tumor]]s, sometimes fatal; and [[blood lipid]] changes that are known to be associated with increased risk of [[atherosclerosis]]" as well as "[[cholestatic hepatitis]], [[hypercalcemia]] in patients with [[breast cancer]], and increased risk for the development of [[prostatic hypertrophy]] and [[prostatic carcinoma]] in [[geriatrics|geriatric patients]]."<ref name="OxandroloneFDAwithdrawal"/> Gemini and [[Sandoz]] requested that FDA withdraw approval and waived their opportunity for a hearing.<ref name="OxandroloneFDAwithdrawal"/>
==Medical uses==
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