FDA withdraws approval of Anavar - filthy behaviour from manufacturer

[bixt]

So heres the deal, I copy paste post by Virtuous from PM:

"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."

 

[bixt]

The FDA has withdrawn approval for OXANDRIN (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg drug products due to sufficiently serious potential problems associated with drug - Horizon Blue Cross Blue Shield of New Jersey

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...

www.horizonblue.com

The FDA has withdrawn approval for OXANDRIN (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg drug products due to sufficiently serious potential problems associated with drug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

 

[bixt]

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).

F*** the generic makers too

 

[t_spacemonkey]

99% of people use UGL anavar. i highly doubt anybody gives a crap TBH

 

[tareload]

All About Oxandrolone

Those wishing to experiment with Oxandrolone can try 10mg (with caffeine which apparently helps absorption) no more than twice a week taken directly before the two hardest workouts of the week. This should give noticeable results over a period of several months with little to no side effects...

www.excelmale.com

 

[tareload]

FDA approved, discontinued androgens (FDA orange book)

FDA has just approved norgestrel (progestin) for OTC but all Pharma versions of oxandrolone have been discontinued. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/opill-0075mg-oral-norgestrel-tablet-information Ignorance sure must be bliss.

www.excelmale.com

 

[Nelson Vergel]

Read the letter I sent the FDA

FDA approved, discontinued androgens (FDA orange book)

FDA has just approved norgestrel (progestin) for OTC but all Pharma versions of oxandrolone have been discontinued. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/opill-0075mg-oral-norgestrel-tablet-information Ignorance sure must be bliss.

www.excelmale.com

 

[bixt]

99% of people use UGL anavar. i highly doubt anybody gives a crap TBH

I'm included in that. Other that test, everything else I play with is mostly UGL. So we will be fine.

But there's so many guys, especially older guys who insist on getting legit stuff who will now lose access. They deal with their docs only and have no idea how to obtain UGL.

Prime example is the current HCG situation. I have access thru the black market to illicit imported India pharma HCG. But so many posts all over the net an even here of guys who have stopped HCG in the past year due to non-availability of compounded HCG \ exorbitant price is Pregnyl.

But we missing my point - this is a typical classic example of big pharma GREED.

 

[t_spacemonkey]

I'm included in that. Other that test, everything else I play with is mostly UGL. So we will be fine.

But there's so many guys, especially older guys who insist on getting legit stuff who will now lose access. They deal with their docs only and have no idea how to obtain UGL.

Prime example is the current HCG situation. I have access thru the black market to illicit imported India pharma HCG. But so many posts all over the net an even here of guys who have stopped HCG in the past year due to non-availability of compounded HCG \ exorbitant price is Pregnyl.

But we missing my point - this is a typical classic example of big pharma GREED.

yeah absolutely. and the FDA is nothing more then extension of big pharma. i would not say the indian HCG is black market/illegal. this is legitimate pharma HCG produced by the same companies who supply the US market. they are however not bound to US laws/FDA etc. the shipping is somewhat a gray area but US customs are very lax overall. it is simply impossible for the US to enforce those drug imports

 

[SteveCleves]

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Rick Collins discussing this topic

 

[Fortunate]

Empower sells oxandrolone. I have no idea how they get it or make it. Does anyone have an opinion on what this would do to their supply? I have a few bottles on the shelf. Have not used it out of caution, but would be nice to know I could still get it in the future if it became a treatment option for me.

 

[sammmy]

This is the regular game played by Pharma - modify the drug slightly to get new 20 years of patent protection and represent the new one as much safer.

They do it with the HIV drugs too - Gilead released Tenofovir Disoproxil in 2001, waited for the patent on it to be almost over, to introduce a new safer for the kidney version Tenofovir Alafenamide in 2016 with new 20 years of patent protection.

 

[Wilson7]

Based on a 1984 study. Really? Before decades of clinical use showing safety and efficacy. Nothing but political and cash. T_space is correct, legit UG OX is about as easy to obtain as a T shirt from Amazon if one does their homework. It was never about safety, if it was the FDA wouldn't be pushing more legit users of OX and HRT, trans, non-binary, etc. into the UG market along with many other drugs. This country is a mess.