All About Oxandrolone

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Guided_by_Voices

Well-Known Member
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 assuming train and diet were resulting in progress before the drug was introduced. IME the dosages generally used are unnecessarily large, and using a dose that can be continued for long periods will give better overall results. Dosing every day will result in the drug being in the body during periods when less growth is occurring which shifts the risk/reward profile toward risk.
 
Defy Medical TRT clinic doctor

Gman86

Member
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 assuming train and diet were resulting in progress before the drug was introduced. IME the dosages generally used are unnecessarily large, and using a dose that can be continued for long periods will give better overall results. Dosing every day will result in the drug being in the body during periods when less growth is occurring which shifts the risk/reward profile toward risk.

Have u ever tried taking it sublingually? Or always orally?
 

madman

Super Moderator
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 assuming train and diet were resulting in progress before the drug was introduced. IME the dosages generally used are unnecessarily large, and using a dose that can be continued for long periods will give better overall results. Dosing every day will result in the drug being in the body during periods when less growth is occurring which shifts the risk/reward profile toward risk.

Those wishing to experiment with Oxandrolone can try 10mg (with caffeine which apparently helps absorption)

Hard to believe you would even mention this.....what based on that N=1 so-called piss ant study?

Should be no issues with absorption when taken on an empty stomach.


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 assuming train and diet were resulting in progress before the drug was introduced.

The original prescribing guidelines for oxandrolone stated a daily dosage of 2.5 mg - 20 mg per day and 5-10 mg/day (most common).

Look over any of the RCTs they were dosing once or twice daily.

Such dose/frequency (10 mg twice weekly) will make a shit lick of difference when it comes to having any significant anabolic benefits let alone long-term.

As pre-workout to boost strength/mood.....sure!

The usual dosage for physique- or performance-enhancing purposes is in the range of 15-25 mg per day, taken for 6 to 8 weeks.

When it comes to reaping the anabolic benefits of such compounds let alone any oral AAS they need to be taken daily let alone in high enough doses as blood levels need to be elevated 24/7 if increasing lean muscle tissue (quality dry gains) is one's goal.

The goal is to enhance protein synthesis/offset protein catabolism.

Top it all off that training/diet needs to be on point let alone one's genetics will have the final say!


IME the dosages generally used are unnecessarily large, and using a dose that can be continued for long periods will give better overall results. Dosing every day will result in the drug being in the body during periods when less growth is occurring which shifts the risk/reward profile toward risk.

You are not understanding this.

Blood levels need to be elevated 24/7 to reap the anabolic benefits when using AAS.
 

Stpfan

Active Member
U definitely don’t need any meds

I would really look into diet if I were u. The body cannot function properly without getting the micronutrients it needs. Are u eating organ meats or taking desiccated organ supplements? Are u getting iodine in ur diet? My money is ur not, so to expect ur body to function properly without them is absolutely insane, no offense. It’s actually the opposite. If ur not getting these things on a regular basis, along with all the other micronutrients the body needs, I would be confused if everything was functioning properly. If ur not giving ur body what it needs, it doesn’t make sense to be surprised when things don’t function properly. I know it’s not what u want to hear, but just trying to save u time and aggravation. There’s no reason why u can’t look into all the avenues ur looking into for solutions, but in the meantime u need to give ur body what it needs

When your meals are balanced and you are eating lean and still getting complexed carbs along with proper healthy fats... what more do you want? When your cholesterol levels are perfect... what more do you want? I don't see how a basic trace mineral is going to make you horny... or increase an erection?

I have an appointment with my Endo in the near future. Tell me what labs you'd like to see... and I will request them. List whatever you want... anything ED related. Vitamin labs... anything... I'm due for a full scale lab report anyway.

Where should your TSH be at optimal levels to prevent ED?
 

Gman86

Member
When your meals are balanced and you are eating lean and still getting complexed carbs along with proper healthy fats... what more do you want? When your cholesterol levels are perfect... what more do you want? I don't see how a basic trace mineral is going to make you horny... or increase an erection?

I have an appointment with my Endo in the near future. Tell me what labs you'd like to see... and I will request them. List whatever you want... anything ED related. Vitamin labs... anything... I'm due for a full scale lab report anyway.

Where should your TSH be at optimal levels to prevent ED?

There’s no specific range for TSH to be in to prevent ED. It’s about getting ur body optimal, and then letting it heal itself in all areas. The body is the most amazing machine ever. U give it what it needs, and remove the things that hurts it, and watch what it can do. For optimal functioning in all areas u ideally want ur TSH below 1. And if that’s not possible, u just don’t want it to go above 2. Anything above 2 usually means hypothyroidism. And if ur running completely on endogenous thyroid production, u don’t want ur TSH too low either. U want it above 0.5 ideally. But if ur on thyroid meds, it doesn’t matter how low ur TSH goes.

The body only functions properly in all areas if ur consistently giving it all the vitamins, minerals and halogens it needs. That’s literally how the body works. To think they’re not that important, in regards to any bodily function, is literally insane lol. It’s basic anatomy and physiology. If the body doesn’t get the vitamins, minerals and halogens it needs, in the proper ratios, u’ll always be chasing ur tail. Macros are only important to hit ur calorie requirement for the day. What really matters is micronutrients.

Spending money on testing, when u already know that ur not getting enough of certain vitamins, minerals and halogens doesn’t make any sense. For instance, if u were inside 24/7 and never saw the sun, why would u test for vitamin D? U already know ur low in it. Testing to find that out would be a waste of money

U can listen to me or not, but ur only hurting urself if u don’t learn about and focus on giving ur body the micronutrients it needs. U clearly have issues with ur thyroid. Do u know that iodine is one of the number one micronutrients that helps the thyroid function properly? Where in ur diet are u getting ur iodine from? Do u know that retinol is one of the most important vitamins for overall health and for all processes of the body to function properly? What in ur diet is giving u retinol? I don’t mind teaching u how to get the micronutrients ur body needs to function properly, and to help ur body have and maintain erections, but u obv have to be willing to learn. And like I said, getting the micronutrients ur body needs doesn’t have to be the only thing u focus on to improve erections. I’m just saying that this should be the main thing u focus on, and then I would also explore any other options u think would help at the same time.

Speaking of erections, I just had two solid ones in the middle of the night last night. That hasn’t happened in a bit. I’ll usually get mornjng wood, but random solid erections when I’m sleeping isn’t usually a thing. Only things that I’ve changed recently is slowly titrating up my aromasin dose, and starting a small dose of P5P everyday to lower prolactin. I’ve only been taking 25mg of it per day. Have u ever taken it? It’s just the active form of B6. But just goes to show how powerful vitamins/ micronutrients can be, in regards to manipulating functions of the body
 

Guided_by_Voices

Well-Known Member
Those wishing to experiment with Oxandrolone can try 10mg (with caffeine which apparently helps absorption)

Hard to believe you would even mention this.....what based on that N=1 so-called piss ant study?

Should be no issues with absorption when taken on an empty stomach.


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 assuming train and diet were resulting in progress before the drug was introduced.

The original prescribing guidelines for oxandrolone stated a daily dosage of 2.5 mg - 20 mg per day and 5-10 mg/day (most common).

Look over any of the RCTs they were dosing once or twice daily.

Such dose/frequency (10 mg twice weekly) will make a shit lick of difference when it comes to having any significant anabolic benefits let alone long-term.

As pre-workout to boost strength/mood.....sure!

The usual dosage for physique- or performance-enhancing purposes is in the range of 15-25 mg per day, taken for 6 to 8 weeks.

When it comes to reaping the anabolic benefits of such compounds let alone any oral AAS they need to be taken daily let alone in high enough doses as blood levels need to be elevated 24/7 if increasing lean muscle tissue (quality dry gains) is one's goal.

The goal is to enhance protein synthesis/offset protein catabolism.

Top it all off that training/diet needs to be on point let alone one's genetics will have the final say!


IME the dosages generally used are unnecessarily large, and using a dose that can be continued for long periods will give better overall results. Dosing every day will result in the drug being in the body during periods when less growth is occurring which shifts the risk/reward profile toward risk.

You are not understanding this.

Blood levels need to be elevated 24/7 to reap the anabolic benefits when using AAS.
The study showing greater absorption with caffeine is in the following link, and while it is only one study, it is a classic case of “it won’t hurt and it might help” as long as you tolerate caffeine. I use a lower dose however to minimize any cortisol response. Can a few hundred mils of caffeine boost the anabolic effect of oxandrolone?

Regarding dosage, people should try for themselves. The dosages that I see people reporting side effects with would be astronomical and unnecessary for those who respond well to smaller doses. Crushed HDL is an almost universal problem and a reduced dose seems to be the only way to reduce that issue. If the lower dose doesn’t work for someone, there was no harm in trying. Just like many of us do best on TRT dosages that would have been considered laughable a few years ago (80-90mg per week in some cases) there seem to be more people realizing that “harsh” compounds are no longer harsh but still beneficial and very low doses. If someone wants to use a higher dose and it works well for them, fine, but my experience clearly shows that typical dosing and/or every day dosing is neither necessary or, in most cases, desirable.

Regarding timing, the things that affect protein synthesis vary over time (such as protein itself) and my memory of the studies that have looked at muscle growth have shown that it is concentrated in the 48 hour period after a stimulus, hence it seems reasonable to think that concentrating the drug levels during that period would make sense. Again I am not talking about getting the maximal benefit but rather about getting acceptable benefit without side effects.

As an aside, as Nelson posted, the formal dosing recommendations for Oxandrolone were based on therapeutic situations such as treating burn patients where rapid short term benefits make sense, however as someone who has been lifting for a long time, if I can add 10-20lbs per year to my major lifts, that is fantastic progress and all I am looking for. Not outgaining my joints is a much higher priority.

Also, the potential for visceral fat reduction from Oxandrolone is likely its biggest health benefit, and also something that argues for lower-for-longer dosing.
 

Gman86

Member
The study showing greater absorption with caffeine is in the following link, and while it is only one study, it is a classic case of “it won’t hurt and it might help” as long as you tolerate caffeine. I use a lower dose however to minimize any cortisol response. Can a few hundred mils of caffeine boost the anabolic effect of oxandrolone?

Regarding dosage, people should try for themselves. The dosages that I see people reporting side effects with would be astronomical and unnecessary for those who respond well to smaller doses. Crushed HDL is an almost universal problem and a reduced dose seems to be the only way to reduce that issue. If the lower dose doesn’t work for someone, there was no harm in trying. Just like many of us do best on TRT dosages that would have been considered laughable a few years ago (80-90mg per week in some cases) there seem to be more people realizing that “harsh” compounds are no longer harsh but still beneficial and very low doses. If someone wants to use a higher dose and it works well for them, fine, but my experience clearly shows that typical dosing and/or every day dosing is neither necessary or, in most cases, desirable.

Regarding timing, the things that affect protein synthesis vary over time (such as protein itself) and my memory of the studies that have looked at muscle growth have shown that it is concentrated in the 48 hour period after a stimulus, hence it seems reasonable to think that concentrating the drug levels during that period would make sense. Again I am not talking about getting the maximal benefit but rather about getting acceptable benefit without side effects.

As an aside, as Nelson posted, the formal dosing recommendations for Oxandrolone were based on therapeutic situations such as treating burn patients where rapid short term benefits make sense, however as someone who has been lifting for a long time, if I can add 10-20lbs per year to my major lifts, that is fantastic progress and all I am looking for. Not outgaining my joints is a much higher priority.

Also, the potential for visceral fat reduction from Oxandrolone is likely its biggest health benefit, and also something that argues for lower-for-longer dosing.

What dose do u personally use, and how often?
 

madman

Super Moderator
The study showing greater absorption with caffeine is in the following link, and while it is only one study, it is a classic case of “it won’t hurt and it might help” as long as you tolerate caffeine. I use a lower dose however to minimize any cortisol response. Can a few hundred mils of caffeine boost the anabolic effect of oxandrolone?

Regarding dosage, people should try for themselves. The dosages that I see people reporting side effects with would be astronomical and unnecessary for those who respond well to smaller doses. Crushed HDL is an almost universal problem and a reduced dose seems to be the only way to reduce that issue. If the lower dose doesn’t work for someone, there was no harm in trying. Just like many of us do best on TRT dosages that would have been considered laughable a few years ago (80-90mg per week in some cases) there seem to be more people realizing that “harsh” compounds are no longer harsh but still beneficial and very low doses. If someone wants to use a higher dose and it works well for them, fine, but my experience clearly shows that typical dosing and/or every day dosing is neither necessary or, in most cases, desirable.

Regarding timing, the things that affect protein synthesis vary over time (such as protein itself) and my memory of the studies that have looked at muscle growth have shown that it is concentrated in the 48 hour period after a stimulus, hence it seems reasonable to think that concentrating the drug levels during that period would make sense. Again I am not talking about getting the maximal benefit but rather about getting acceptable benefit without side effects.

As an aside, as Nelson posted, the formal dosing recommendations for Oxandrolone were based on therapeutic situations such as treating burn patients where rapid short term benefits make sense, however as someone who has been lifting for a long time, if I can add 10-20lbs per year to my major lifts, that is fantastic progress and all I am looking for. Not outgaining my joints is a much higher priority.

Also, the potential for visceral fat reduction from Oxandrolone is likely its biggest health benefit, and also something that argues for lower-for-longer dosing.

The study showing greater absorption with caffeine is in the following link, and while it is only one study, it is a classic case of “it won’t hurt and it might help” as long as you tolerate caffeine. I use a lower dose however to minimize any cortisol response. Can a few hundred mils of caffeine boost the anabolic effect of oxandrolone?

Again a piss ant study....1 subject!


Regarding dosage, people should try for themselves.

No harm in trying a lower dose 5-10 mg if it makes sense meaning it is dosed properly as in daily/split twice daily not once or twice weekly as you stated which will make a shit lick of difference when it comes to reaping the anabolic benefits.

As a pre-workout to boost mood/strength.....sure.


The dosages that I see people reporting side effects with would be astronomical and unnecessary for those who respond well to smaller doses. Crushed HDL is an almost universal problem and a reduced dose seems to be the only way to reduce that issue. If the lower dose doesn’t work for someone, there was no harm in trying.

Again the usual dosage for physique- or performance-enhancing purposes is in the range of 15-25 mg per day, taken for 6 to 8 weeks.

The original prescribing guidelines for Var called for a daily dosage of between 2.5 mg and 20 mg per day (5-10 mg being the most common).

Most clinics are prescribing anywhere from 15-25 mg/day which they tend to consider therapeutic.

Many men abusing the compound for the sole purpose of muscle enhancement/strength gains will use upwards of 40-80 mg/day.

Even if one were to try a lower dose of 5-10 mg it needs to be taken daily!


If the lower dose doesn’t work for someone, there was no harm in trying. Just like many of us do best on TRT dosages that would have been considered laughable a few years ago (80-90mg per week in some cases) there seem to be more people realizing that “harsh” compounds are no longer harsh but still beneficial and very low doses.

This is still going over your head.

Blood levels need to be elevated 24/7 to reap the anabolic benefits when using AAS.

Oral AAS needs to be taken daily due to the half-life!

As I stated previously

When it comes to reaping the anabolic benefits of such compounds (oxandrolone) let alone any oral AAS they need to be taken daily in high enough doses as blood levels need to be elevated 24/7 if increasing lean muscle tissue (quality dry gains) is one's goal.

The goal is to enhance protein synthesis/offset protein catabolism daily as in 24/7.

Even for the men on trt who tend to do better using a lower overall weekly dose of T <100 mg/week.....due to the half-life of esterified T levels will eventually reach steady-state.

Even when it comes to the anabolic benefits of testosterone as long as diet/training are on point the changes in body composition (muscle gain/fat loss) from using <100-150 mg T/week would be minor when compared to the doses used for the sole purpose of muscle enhancement/strength gains.

Most would tell you that 200 mg T/week is where the anabolic benefits really start to kick in and even then steroid doses in the 300-600 mg T/week range is where the anabolic benefits truly shine when it comes to muscle enhancement/strength gains.


Regarding timing, the things that affect protein synthesis vary over time (such as protein itself) and my memory of the studies that have looked at muscle growth have shown that it is concentrated in the 48 hour period after a stimulus, hence it seems reasonable to think that concentrating the drug levels during that period would make sense. Again I am not talking about getting the maximal benefit but rather about getting acceptable benefit without side effects.

Dosing oxandrolone let alone any oral AAS once/twice weekly is going to make a shit lick of difference when it comes to reaping the anabolic benefits.


As an aside, as Nelson posted, the formal dosing recommendations for Oxandrolone were based on therapeutic situations such as treating burn patients where rapid short term benefits make sense, however as someone who has been lifting for a long time, if I can add 10-20lbs per year to my major lifts, that is fantastic progress and all I am looking for. Not outgaining my joints is a much higher priority.

Again highly doubtful using a low dose of oxandrolone 5-10 mg twice weekly let alone once weekly will have any meaningful impact on muscle enhancement/strength gains long term.

5-10mg daily.....sure.


Also, the potential for visceral fat reduction from Oxandrolone is likely its biggest health benefit, and also something that argues for lower-for-longer dosing.

Definitely but again even when using lower doses it needs to be dosed daily.

Oxandrolone is known for pure lean tissue gains (dry), enhancing strength, accelerating fat loss.

Diet/training protocol will play a big part let alone one's genetics will have the final say.
 
T

tareload

Guest
The study showing greater absorption with caffeine is in the following link, and while it is only one study, it is a classic case of “it won’t hurt and it might help” as long as you tolerate caffeine. I use a lower dose however to minimize any cortisol response. Can a few hundred mils of caffeine boost the anabolic effect of oxandrolone?

Again a piss ant study....1 subject!
I've read this study and can't make any sense of it. Oxandrolone absorption via the oral route (bioavailability) is very high as shown in multiple studies.

In order for the AUCs from the two graphs below to make any sense, the baseline absorption from the first graph had to be incredibly poor, no?

1633030458118.png


1633030473219.png




See here:

1633030896312.png

1633030916554.png
 

Guided_by_Voices

Well-Known Member
What dose do u personally use, and how often?
When my lab rat uses Oxandrolone it is 10 mg pre-workout no more than twice per week, and before the heaviest two workouts of the week. Going on and off of this multiple times over multiple years shows unmistakable benefits after several weeks of use with reduced but acceptable HDL numbers and no other negatives I am aware of. Niacin seems to partially counteract the HDL impact. Even someone not on TRT might benefit although I can't speak to that. Note that some people (like me ) are hyper-responders to almost everything and other people will require larger doses, and as I said above, after 40 years of non-stop lifting I am very attuned to even very small influences which others might not be.
 

Gman86

Member
When my lab rat uses Oxandrolone it is 10 mg pre-workout no more than twice per week, and before the heaviest two workouts of the week. Going on and off of this multiple times over multiple years shows unmistakable benefits after several weeks of use with reduced but acceptable HDL numbers and no other negatives I am aware of. Niacin seems to partially counteract the HDL impact. Even someone not on TRT might benefit although I can't speak to that. Note that some people (like me ) are hyper-responders to almost everything and other people will require larger doses, and as I said above, after 40 years of non-stop lifting I am very attuned to even very small influences which others might not be.

Does ur lab rat swallow it whole or does it let it dissolve sublingually under its little rat tongue? And how long before the workout does it take it?

I’ve been taking 15mg sublingually 3x/week prior to my workouts and I definitely notice a little boost during my workout. My labs weren’t bad at all on 15mg/ day, so I’m sure they’ll be just fine doing 15mg 3x/ week compared to 7 days/ week, and 45mg total per week compared to 105mg total per week
 

Guided_by_Voices

Well-Known Member
He swallows it whole about half an hour before the workout. The most noticeable affect is on leanness, with strength benefits as well. It doesn't hurt workout intensity but I don't notice much of a difference in that regard.
I came across some other discussion several years ago on sublingual dosing and the best evidence seemed to be that a compound has to be formulated specifically to be absorbed sublingually and not everything could be administered that way so I have not tried that approach but perhaps I will since the worst case is that it would just eventually be swallowed and absorbed that way. On the other hand, one of the famous doping regimes from a few years ago apparently involved taking fairly common anabolics and swishing them around in the mouth, so perhaps it is possible although that may have been to avoid some sort of metabolite that the tests would pick up if they were swallowed, so bottom line is I don't know one way or the other but I will give it a try. I am confident that many things cannot be absorbed transdermally, so I would think that would be true of sublingual as well.
 

Gman86

Member
He swallows it whole about half an hour before the workout. The most noticeable affect is on leanness, with strength benefits as well. It doesn't hurt workout intensity but I don't notice much of a difference in that regard.
I came across some other discussion several years ago on sublingual dosing and the best evidence seemed to be that a compound has to be formulated specifically to be absorbed sublingually and not everything could be administered that way so I have not tried that approach but perhaps I will since the worst case is that it would just eventually be swallowed and absorbed that way. On the other hand, one of the famous doping regimes from a few years ago apparently involved taking fairly common anabolics and swishing them around in the mouth, so perhaps it is possible although that may have been to avoid some sort of metabolite that the tests would pick up if they were swallowed, so bottom line is I don't know one way or the other but I will give it a try. I am confident that many things cannot be absorbed transdermally, so I would think that would be true of sublingual as well.

Those were my exact thoughts. Worst case scenario I’ll just swallow it and it will get absorbed that way. Here’s some vids I came across about taking orals sublingually if u want to check them out. They’re what got me interested in taking Oxandrolone pre workout, and also taking it sublingually. I stopped taking it daily, cuz it lowered my SHBG down to 11, from mid 30’s, and 11 is a bit too low for my liking. Plus it was getting pretty expensive taking the 15mg of compounded Oxandrolone daily. But taking it only 3x/ week is affordable, and I doubt it will lower my SHBG as drastically with me taking less than half of the dose I was on before per week.



 

Nelson Vergel

Founder, ExcelMale.com
 

Nelson Vergel

Founder, ExcelMale.com
Pharma may soon abandon Oxandrolone (Oxandrin)
More details are coming soon.

Oxandrolone

Oxandrolone is characterized by a modification in the basic structure of testosterone to include a substitution of an oxygen atom in place of the methylene group at the C2 position in the steroid ring, this molecule has a 17-alkylated group at the C17 position that prevents deactivation of this steroid by hepatic first-pass metabolism - allowing for oral administration. Given these alterations, oxandrolone also shows resistance to hepatic metabolism further enhancing action [20]. While mild elevations in hepatic transaminases have been noted [45], oxandrolone is not known for significant hepatic side effects such as cholestasis, peliosis hepatis, hepatic adenomas, and hepatocellular carcinomas. Minor adverse events have been noted in clinical trials on oxandrolone including alterations in cholesterol levels [20].

Similar to nandrolone, oxandrolone has marked anabolic activity, with a myotrophic/androgenic ratio of 10:1 [46]. It has shown clinical efficacy in acute catabolic disorders such as severe burn injuries, after extensive surgery, and severe trauma. There have also been positive clinical outcomes in chronic catabolic disorders such as the treatment of HIV/AIDS-associated wasting [47], neuromuscular diseases such as Duchenne muscular dystrophy [48], amyotrophic lateral sclerosis [45], and COPD [49]. Oxandrolone is also used to offset the protein catabolism associated with long-term corticosteroid use and relief of the bone pain accompanying osteoporosis [20].

As with nandrolone, the reproductive effects of oxandrolone are not well studied. Several case reports note reversible steroid-induced azoospermia with oxandrolone use in combination with other AAS [50, 51]. Caution should be employed in all men of reproductive age given known effects on the LH/FSH axis and the potential resultant effects on spermatogenesis.

Source: Wu, C. & Kovac, J.R. Curr Urol Rep (2016) 17: 72.
History:

Oxandrolone was first described in 1962. It was developed into a medicine several years later by pharmaceutical giant G.D. Searle & Co. (now Pfizer), which sold it in the United States and the Netherlands under the Anavar trade name. Searle also sold/licensed the drug under different trade names including Lonavar (Argentina, Australia), Lipidex (Brazil), Antitriol (Spain), Anatrophill (France), and Protivar. Oxandrolone was designed to be an extremely mild oral anabolic, one that could even be used safely by women and children. In this regard Searle seems to have succeeded, as Anavar has shown a high degree of therapeutic success and tolerability in men, women, and children alike. During its early years, Anavar had been offered for a number of therapeutic applications, including the promotion of lean tissue growth during catabolic illness, the promotion of lean tissue growth following surgery, trauma, infection, or prolonged corticosteroid administration, or the support of bone density in patients with osteoporosis.

By the 1980's, the FDA had slightly refined the approved applications of Anavar to include the promotion of weight gain following surgery, chronic infection, trauma, or weight loss without definite pathophysiologic reason. In spite of its ongoing track record of safety, Searle decided to voluntarily discontinue the sale of Anavar on July 1, 1989. Lagging sales and growing public concern about the athletic use of anabolic steroids appeared to be at the root of this decision. With the Anavar brand off the market, oxandrolone had completely vanished from U.S. pharmacies. Soon after, oxandrolone products in international markets (often sold by or under license from Searle) began to disappear as well, as the leading global manufacturer of the drug continued its withdrawal from the anabolic steroid business. For several years during the early 1990's, it looked as if Anavar might be on its way out of commerce for good.

Approximately six years would pass before oxandrolone tablets would return to the U.S. market. The product returned to pharmacy shelves in December 1995 under the Oxandrin name by Bio-Technology General Corp. (BTG). BTG would continue selling it for FDA-approved uses involving lean mass preservation, but had also been granted orphan-drug status for treating AIDS wasting, alcoholic hepatitis, Turner's syndrome in girls, and constitutional delay of growth and puberty in boys. Orphan drug status gave BTG a 7-year monopoly on the drug for these new uses, allowing them to protect a very high selling price. Many patients were outraged to learn that the drug would cost them (at wholesale price) between $3.75 and $30 per day, many times more costly than Anavar had been just several years back. The release of a 10 mg tablet from BTG several years later did little to reduce the relative cost of the drug.

Source
 
T

tareload

Guest
Pharma ...

Oxandrolone (Oxandrin)


For example, no Pharma ND or stanozolol now. Compounded? Yes both.
 
Last edited by a moderator:

madman

Super Moderator
Damn!

*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

* Distribution of Gemini's OXANDRIN (oxandrolone) tablets, 2.5 mg and 10 mg; Sandoz's oxandrolone tablets 2.5 mg and 10 mg; Par's oxandrolone tablets, 2.5 mg and 10 mg; or Upsher-Smith's oxandrolone tablets, 2.5 mg and 10 mg, into interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d))







In a letter dated March 26, 2019, Gemini requested that FDA withdraw approval of NDA 013718 for OXANDRIN (oxandrolone) tablets, 2.5 mg and 10 mg, under §  314.150(c) (21 CFR 314.150(c)), stating that the product was no longer being marketed. Subsequently, on December 16, 2022, FDA notified Gemini and other holders of approved applications that the Agency believes a potential problem associated with oxandrolone tablets is sufficiently serious that the drug products should be removed from the market, and to enable withdrawal of approval of their applications under §  314.150(d).


The anabolic steroid OXANDRIN (oxandrolone) tablets, 2.5 mg and 10 mg, under NDA 013718, is indicated as follows: “as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis.” [1] FDA initially approved NDA 013718 in 1964.


In January 1984, FDA's Endocrinologic and Metabolic Drugs Advisory Committee met and discussed anabolic steroids. The advisory committee unanimously concluded that there was no evidence of efficacy for oxandrolone.[2]


As communicated in the product labeling, multiple safety warnings and precautions are associated with the use of oxandrolone tablets including peliosis hepatis, sometimes associated with liver failure and intra-abdominal hemorrhage; liver cell tumors, sometimes fatal; and blood lipid changes that are known to be associated with increased risk of atherosclerosis.[3] Per the labeling, additional warnings with using this product include the risks associated with cholestatic hepatitis, hypercalcemia in patients with breast cancer, and increased risk for the development of prostatic hypertrophy and prostatic carcinoma in geriatric patients.[4]


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.


After FDA notified Gemini that it believes the potential problems associated with the drug are sufficiently serious that the drug should be removed from the market pursuant to § 314.150(d), Gemini requested in a letter dated December 19, 2022 that FDA withdraw approval of NDA 013718 under §  314.150(d). Gemini waived its opportunity for a hearing. In a letter dated December 23, 2022, Sandoz requested that FDA withdraw approval of ANDA 076897 under §  314.150(d). Sandoz waived its opportunity for a hearing. In a letter dated January 5, 2023, Par requested that FDA withdraw approval of ANDA 077827 under §  314.150(d). Par waived its opportunity for a hearing. In separate letters dated January 6, 2023, Upsher-Smith requested that FDA withdraw approval of ANDAs 078033 and 076761 under §  314.150(d). Upsher-Smith waived its opportunity for a hearing.


Therefore, for the reasons discussed above, which the applicants do not dispute in their letters requesting withdrawal of approval under §  314.150(d), FDA's approval of NDA 013718 and ANDAs 076897, 077827, 078033, and 076761, and all amendments and supplements thereto, are withdrawn (see DATES). Distribution of Gemini's OXANDRIN (oxandrolone) tablets, 2.5 mg and 10 mg; Sandoz's oxandrolone tablets 2.5 mg and 10 mg; Par's oxandrolone tablets, 2.5 mg and 10 mg; or Upsher-Smith's oxandrolone tablets, 2.5 mg and 10 mg, into interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).


Dated: June 23, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.




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T

tareload

Guest















Laughable. Let me know if you would like me to continue. There is no debate on clinical efficacy and risk/reward of oxandrolone.


 
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