FDA Bans Anavar
- Thread starter Drolball
- Start date
sns8778
Board Sponsor
Here is the full context of this from another article, in which it specifies that it was the drug company themselves that petitioned the FDA to withdraw the its approval for Oxandrolone, as related to osteoporosis.
Invalid Link Removed
On June 28, 2023, the FDA published their final approval of Gemini US’s voluntary 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).
Background: 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
Invalid Link Removed
On June 28, 2023, the FDA published their final approval of Gemini US’s voluntary 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).
Background: 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
Drolball
Member
Ohh my mistake. Thanks for clarifying. Wonder why it's taking so long then.
sns8778
Board Sponsor
No worries at all. I know that some of this stuff and the terminology can be hard to understand or interpret.
In the case of the delays you've ran into, it could be a coincidence or it could be that the situation impacted the supply chain for the drug somehow. Sometimes, even pharmacy distributors may be freaked out by news of things like that. It's hard to know for sure.
sns8778
Board Sponsor
Oxandrolone had already been approved by the FDA to help relieve bone pain in 1964 for osteoporosis.
In 1984, an FDA committee decided that there was not enough evidence for the efficacy of tablets - not the drug, just in tablet form.
And also for context, these types of committee decisions weigh the effectiveness by the standards of the time so something that helped by 1964's standards may be far less impressive 20 years later as compared to other available options.
The reason that they're 'just now doing this' is that the pharmaceutical company that had the application asked the FDA to withdraw the application. The FDA didn't just do it on their own - the pharmaceutical company asked them to.
That would normally indicate that the pharma company didn't view it as viable anymore for the drug to prescribed for the the desired application. That doesn't mean they're saying it doesn't work for other things, it actually doesn't mean that they're saying it doesn't even work for that; just that its not viable to continue to prescribe for that purpose. Which I would agree with in this case, because its been so long since its been prescribed for pain in osteoporosis that most people probably don't realize that it ever even was.
I hope that makes sense and helps clarify it. Stuff like this can be super confusing to understand the terminology.
BBiceps
Well-known member
Idk but it could have something to do with your insurance, your insurance will most likely not cover it and that’s why the pharmacy have issues to fill it. I would (have) call the pharmacy to check or/and shop around to find the cheapest Pharmacy/Compound Pharmacy (I did) because Pharmacy Var is not cheap.
Drolball
Member
I don’t think that’s the case because they've covered it the last 4 scripts. The pharmacy I’m trying to get it from doesn’t have it in stock and they ordered it, but nothing’s shipped from the manufacturer yet. I even called my old pharmacy that filled it the last 3 times and they're out of stock with order issues as well. I think SNS might be right with the supply chain issue.