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Clinical Use of Anabolics and Hormones
Clinical Use of Anabolics and Hormones
FDA withdraws approval of Anavar - filthy behaviour from manufacturer
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<blockquote data-quote="bixt" data-source="post: 262878" data-attributes="member: 39921"><p>[URL unfurl="true"]https://www.horizonblue.com/providers/news/news-legal-notices/fda-has-withdrawn-approval-oxandrin-oxandrolone-tablets-2-5-milligrams-mg-and-10-mg-drug-products[/URL]</p><p></p><p></p><p>The FDA has withdrawn approval for OXANDRIN (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg drug products due to sufficiently serious potential problems associated with drug</p><p></p><p><strong>On June 28, 2023</strong>, the FDA published their final approval of Gemini US’s <strong>voluntary</strong> withdrawal request of NDA for OXANDRIN (oxandrolone) tablets) tablets, 2.5 milligrams (mg) and 10 mg.. FDA is also withdrawing approval of four abbreviated new drug applications for Oxandrolone from Upsher-Smith Laboratories, LLC (Upsher-Smith), Par Pharmaceutical, Inc. (Par), and Sandoz Inc. (Sandoz).</p><p></p><p><strong>Background:</strong> Oxandrin was approved by the FDA in 1964 to relieve bone pain in osteoporosis. However, in 1984 an FDA advisory committee concluded there was no evidence of efficacy for tablets.</p><p></p><p>Additionally, as communicated in the product labeling, multiple safety warnings and precautions have been associated with the use of oxandrolone tablets. These include pelosis hepatitis, sometimes associated with liver failure and intra-abdominal hemorrhage; live cell tumors, sometimes fatal; and blood lipid changes that are associated with increased risk of atherosclerosis. Other warnings have been related to risks of cholestatic hepatitis, hypercalcemia in patients with breast cancer, and increased risk for the development of prostatic carcinoma and prostatic hypertrophy in geriatric patients.</p><p></p><p>In December of 2022, Gemini requested a voluntary withdrawal of their approved FDA application. Based on FDA's review of currently available data and information regarding the safety and effectiveness of oxandrolone tablets, the Agency believes that the potential problems associated with oxandrolone tablets are sufficiently serious that the drug should be removed from the market</p><p></p><p><strong>For Further Information Contact:</strong></p><p>Alexandra Fujisaki,</p><p>Center for Drug Evaluation and Research</p><p>Food and Drug Administration</p><p>10903 New Hampshire Ave. Bldg. 51 Rm. 6222</p><p>Silver Spring, MD, 20093</p><p>301-796 – 3600</p><p><a href="mailto:Alexandria.Fujisaki@fda.hhs.gov">Alexandria.Fujisaki@fda.hhs.gov</a></p><p></p><p>Sources:</p><ol> <li data-xf-list-type="ol">Department Of Health and Human Services. Retrieved July 28, 2023 from<br /> <a href="https://public-inspection.federalregister.gov/2023-13733.pdf" target="_blank">https://public-inspection.federalregister.gov/2023-13733.pdfhttps://public-inspection.federalregister.gov/2023-13733.pdf opens a dialog window</a></li> <li data-xf-list-type="ol">Federal Register. Retrieved on July 28, 2023<br /> <a href="https://www.govinfo.gov/content/pkg/FR-2023-06-28/pdf/2023-13733.pdf" target="_blank">https://www.govinfo.gov/content/pkg/FR-2023-06-28/pdf/2023-13733.pdfhttps://www.govinfo.gov/content/pkg/FR-2023-06-28/pdf/2023-13733.pdf opens a dialog window</a></li> <li data-xf-list-type="ol">Regulations.gov. Retrieved on July 28,2023<br /> <a href="https://www.regulations.gov/document/FDA-2023-N-2226-0001" target="_blank">https://www.regulations.gov/document/FDA-2023-N-2226-0001https://www.regulations.gov/document/FDA-2023-N-2226-0001 opens a dialog window</a></li> </ol></blockquote><p></p>
[QUOTE="bixt, post: 262878, member: 39921"] [URL unfurl="true"]https://www.horizonblue.com/providers/news/news-legal-notices/fda-has-withdrawn-approval-oxandrin-oxandrolone-tablets-2-5-milligrams-mg-and-10-mg-drug-products[/URL] The FDA has withdrawn approval for OXANDRIN (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg drug products due to sufficiently serious potential problems associated with drug [B]On June 28, 2023[/B], the FDA published their final approval of Gemini US’s [B]voluntary[/B] withdrawal request of NDA for OXANDRIN (oxandrolone) tablets) tablets, 2.5 milligrams (mg) and 10 mg.. FDA is also withdrawing approval of four abbreviated new drug applications for Oxandrolone from Upsher-Smith Laboratories, LLC (Upsher-Smith), Par Pharmaceutical, Inc. (Par), and Sandoz Inc. (Sandoz). [B]Background:[/B] Oxandrin was approved by the FDA in 1964 to relieve bone pain in osteoporosis. However, in 1984 an FDA advisory committee concluded there was no evidence of efficacy for tablets. Additionally, as communicated in the product labeling, multiple safety warnings and precautions have been associated with the use of oxandrolone tablets. These include pelosis hepatitis, sometimes associated with liver failure and intra-abdominal hemorrhage; live cell tumors, sometimes fatal; and blood lipid changes that are associated with increased risk of atherosclerosis. Other warnings have been related to risks of cholestatic hepatitis, hypercalcemia in patients with breast cancer, and increased risk for the development of prostatic carcinoma and prostatic hypertrophy in geriatric patients. In December of 2022, Gemini requested a voluntary withdrawal of their approved FDA application. Based on FDA's review of currently available data and information regarding the safety and effectiveness of oxandrolone tablets, the Agency believes that the potential problems associated with oxandrolone tablets are sufficiently serious that the drug should be removed from the market [B]For Further Information Contact:[/B] Alexandra Fujisaki, Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave. Bldg. 51 Rm. 6222 Silver Spring, MD, 20093 301-796 – 3600 [EMAIL]Alexandria.Fujisaki@fda.hhs.gov[/EMAIL] Sources: [LIST=1] [*]Department Of Health and Human Services. Retrieved July 28, 2023 from [URL='https://public-inspection.federalregister.gov/2023-13733.pdf']https://public-inspection.federalregister.gov/2023-13733.pdfhttps://public-inspection.federalregister.gov/2023-13733.pdf opens a dialog window[/URL] [*]Federal Register. Retrieved on July 28, 2023 [URL='https://www.govinfo.gov/content/pkg/FR-2023-06-28/pdf/2023-13733.pdf']https://www.govinfo.gov/content/pkg/FR-2023-06-28/pdf/2023-13733.pdfhttps://www.govinfo.gov/content/pkg/FR-2023-06-28/pdf/2023-13733.pdf opens a dialog window[/URL] [*]Regulations.gov. Retrieved on July 28,2023 [URL='https://www.regulations.gov/document/FDA-2023-N-2226-0001']https://www.regulations.gov/document/FDA-2023-N-2226-0001https://www.regulations.gov/document/FDA-2023-N-2226-0001 opens a dialog window[/URL] [/LIST] [/QUOTE]
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Clinical Use of Anabolics and Hormones
Clinical Use of Anabolics and Hormones
FDA withdraws approval of Anavar - filthy behaviour from manufacturer
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