Good night US FDA Oxandrolone

[Rido]

Oxandrolone appears to have been withdrawn from US FDA approval.

Federal Register :: Request Access

 

[lukiss96]

So it means no more prescription unless you pay good chunk of $$$ for it?

Shame, cuz oxandrolone is really great, but hey I guess most of us get it from somewhere else anyway and in EU I doubt we ever had such access to drugs like you guys have in USA.

 

[Rido]

So it means no more prescription unless you pay good chunk of $$$ for it?

Shame, cuz oxandrolone is really great, but hey I guess most of us get it from somewhere else anyway and in EU I doubt we ever had such access to drugs like you guys have in USA.

not even for $(atleast legally).

Just flat out discontinued in the US. most of us rarely had access to real pharma US anavar anyways.


I dont think the compounding pharmacies will be allowed to dispense it anymore either.

 

[petefox]

Sounds like it's not approved for specific applications, at least that's what I'm reading. Might look into it and ask a few docs what they might know.

Like maybe it won't be used off-script for burn victims anymore, as that was one of its uses clinically (not a regular use-case).

 

[Rido]

Sounds like it's not approved for specific applications, at least that's what I'm reading. Might look into it and ask a few docs what they might know.

Like maybe it won't be used off-script for burn victims anymore, as that was one of its uses clinically (not a regular use-case).

I disagree. looks like a hard withdrawal for all indications.

I dont think it can even be prescribed off label anymore.

 

[petefox]

Yeah, read further in the report and a few other spots. They decided the juice ain't worth the squeeze (lipidemia, kidney issues, liver tumors) so they decided to stop production.

Jano gonna make some $$ from this, for sure.

 

[sbdman]

“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approval of NDA 013718 and ANDAs 076897, 077827, 078033, and 076761, and all amendments and supplements thereto, are withdrawn (see DATES).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)).

I’m a lawyer and this is not my area of but my take from this based upon the above is that the drug cannot be distributed across state lines unless there’s an approved application. A compounding pharmacy operating entirely “in-state” could theoretically still dispense it but only if it has an approved application as defined by the FDA (whatever that may be).

This is definitely a case of federal vs state law and its interplay, and any compounding pharmacy seeking to dispense the drug should consult with an experienced FDA specialized attorney.

 

[Rido]

“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)).

I’m a lawyer and this is not my area of but my take from this based upon the above is that the drug cannot be distributed across state lines unless there’s an approved application. A compounding pharmacy operating entirely “in-state” could theoretically still dispense it but only if it has an approved application as defined by the FDA (whatever that may be).

This is definitely a case of federal vs state law and its interplay, and any compounding pharmacy seeking to dispense the drug should consult with an experienced FDA specialized attorney.

But the FDA approval has been withdrawn.. a prescriber cannot give it to patients



That "in state" part only applies to distribution of it.

 

[Avarice911]

I just placed an order from my TRT clinic this morning for oxandrolone. Let’s see what happens. I’m in NJ and clinic is in FL.

 

[Rido]

I just placed an order from my TRT clinic this morning for oxandrolone. Let’s see what happens. I’m in NJ and clinic is in FL.

I am sure they are still gonna allow it to go through. Technically shouldn't prescribe HGH either. they still do.

 

[Avarice911]

I am sure they are still gonna allow it to go through. Technically shouldn't prescribe HGH either. they still do.

I’ll keep placing orders as long as they’ll fill them then lol

 

[Rido]

I’ll keep placing orders as long as they’ll fill them then lol

enjoy your overpriced Anavar.

I am pretty damn sure all that shit they sell there is same shit from Chinese factories.

its good if you want the "Legal" Protection

 

[Avarice911]

enjoy your overpriced Anavar.

I am pretty damn sure all that shit they sell there is same shit from Chinese factories.

its good if you want the "Legal" Protection

Yes, it is most certainly for the legal aspect of it. That’s not to say I don’t supplement that with additional anavar tho

 

[sbdman]

I’m definitely getting into the legal weeds of the FDAs letter involving the FDA ability to regulate these substances. Here the FDA is using its authority to regulate interstate commerce through the commerce clause. That’s why the letter uses the specific language that oxandrolone cannot be distributed into interstate commerce (go across state lines). However I will agree that the FDA has now prohibited the drug for any indications.

I guess what I’m trying to say is that this situation is analogous to states allowing the sell of marijuana while the FDA has marijuana listed as a controlled substance federally that has no use for medical treatment. However, here in my home state I’ve been granted a medical card to be prescribed marijuana “instate only” for the treatment of insomnia.

So what I was saying is that compound pharmacies that operates exclusively in one state can likely still dispense the drug provided it’s pursuant to a lawful prescription, and the drug doesn’t cross state lines thereby implicating federal law.

Definitely not trying to be argumentative. Just giving my two cents. But again, I can’t 100% say this is the way things are right now and any person reading this shouldn’t rely on this opinion of the FDAs ruling.

 

[Rido]

I’m definitely getting into the legal weeds of the FDAs letter involving the FDA ability to regulate these substances. Here the FDA is using its authority to regulate interstate commerce through the commerce clause. That’s why the letter uses the specific language that oxandrolone cannot be distributed into interstate commerce (go across state lines). However I will agree that the FDA has now prohibited the drug for any indications.

I guess what I’m trying to say is that this situation is analogous to states allowing the sell of marijuana while the FDA has marijuana listed as a controlled substance federally that has no use for medical treatment. However, here in my home state I’ve been granted a medical card to be prescribed marijuana “instate only” for the treatment of insomnia.

So what I was saying is that compound pharmacies that operates exclusively in one state can likely still dispense the drug provided it’s pursuant to a lawful prescription, and the drug doesn’t cross state lines thereby implicating federal law.

Definitely not trying to be argumentative. Just giving my two cents. But again, I can’t 100% say this is the way things are right now and any person reading this shouldn’t rely on this opinion of the FDAs ruling.

oh its good to have this insight 100%.

in the end, nothing will change personally.