FDA Withdraws Approval for Anavar

[danieltx]

https://www.horizonblue.com/provide...ets-2-5-milligrams-mg-and-10-mg-drug-products

The FDA has withdrawn approval for OXANDRIN (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg drug products due to sufficiently serious potential problems associated with drug

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

For Further Information Contact:
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 protected]

Sources:

1. Department Of Health and Human Services. Retrieved July 28, 2023 from
   https://public-inspection.federalregister.gov/2023-13733.pdfhttps://public-inspection.federalregister.gov/2023-13733.pdf opens a dialog window‌
2. Federal Register. Retrieved on July 28, 2023
   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
3. Regulations.gov. Retrieved on July 28,2023
   https://www.regulations.gov/document/FDA-2023-N-2226-0001https://www.regulations.gov/document/FDA-2023-N-2226-0001 opens a dialog window

 

[KillerStack]

So what is actually going on here?

 

[CorgisOnTren]

So what is actually going on here?

You cannot get prescribed anavar from clinics etc anymore in the US is my understanding

 

[nothuman]

Was anavar actually being prescribed much to begin with?

 

[CorgisOnTren]

Was anavar actually being prescribed much to begin with?

Yeah clinics in US were prescribing it like candy for pretty wild prices

 

[kilsong]

Was anavar actually being prescribed much to begin with?

I dunno. But Mark Lobliner got Anadrol from a trt clinic so who knows.
Go right to the 5 min 40 second mark where he talks about it :

 

[FartJohnson]

Seems a little heavy handed, anavar is genuinely useful as a treatment for muscle wasting in patients with advanced cancer/hiv. Mild, well tolerated, low virilizing effect in women. Can’t really think of an equivalent medicine.

Makes me think this was related to overprescribing of anavar at the TRT clinics.

 

[totalrecomp]

"Oxandrin was approved by the FDA in 1964..."


And now in 2023 it's not safe anymore. Only took them 59 years to sort that one out, but I am sure they are not missing anything with drugs going through standard approval process, or even an expedited one.........................................right?

 

[narta]

I bet there would be a more expensive substitute in thew near future that has an active patent.

 

[Virtuous]

I bet there would be a more expensive substitute in thew near future that has an active patent.

Nailed it.

Anavar’s patent expired, Gemeni asked the FDA to remove approval, and they’ll introduce a slightly modified drug to replace it, with 20 year patent protection.

Cash grab.

Oh well, new drug for us.

 

[A50#]

You cannot get prescribed anavar from clinics etc anymore so in the US is my understanding

My TRT prescribed me some last year. Paid a small fortune for it. Never been a huge fan of Anavar but had to try it again since I could obtain it through a pharmacy with a prescription.

 

[fisther69]

Was anavar actually being prescribed much to begin with?

I had a script for it lol

 

[Fleezy]

hopefully its replacement will be safe and effective

 

[romo]

Thats ok, i can get plenty, prescribed by my sources

 

[Mufasa123]

If I remember correctly if was pulled long ago even when generic. Then with HIV being an issue BTG pharma got it back under accelerated rules BUT new patent cycle so they bought fucking kilos of raws, pressed it into pills and made a fortune. They also launching a new study to lock in the 10mg pills as a separate drug (read that as patent cycle). Basically our gvt was paying for the aids patients so huge tax scam on us when it was generic and known to treat muscle wasting (just not aids specific muscle wasting). Basically for a months supply in a 2.5mg pressed pill it was priced at what you'd buy a kilo of raw for. Talk about a spread like no other and just basic tests no development costs. BTG when on to try to corner the hormone marker for a while under this bullshit. No idea what happened after that.

I was pissed at them fucking the tax payer by fucking dying people in this manner so I sent it all to a journalist who'd been doing anti drug company scam research. Figured it was a layup - went no where though btg may have written him a check to go away.

 

[1fst400]

I’ve always wondered what “therapeutic” purpose a clinic would indicate for anavar as a rx.

I remember it was popular at one point for clinics to rx winstrol for shbg therapy. Not sure if they still do that anymore.

 

[UnholyAlliance]

Now watch customs start seizing packs of Anavar...

 

[stackdizzy]

Guess I am going to have to ask that guy standing on the street corner in a shady part of town if he can get that good good Anavar.

 

[JuicedMayhem]

Don’t worry guys big pharma is only out to protect you, because they love you.

 

[WeakFNG]

I knew a burn victim that was on it while recovering. Up to 60mgs a day at one point and it was a total game changer for them. Its laughable how its not safe anymore