I’m not as familiar with animal med as human - human docs can absolutely prescribe off-label; the manufacturer cannot promote off-label use.
different for vets?
And my understanding of generic meds for humans is “80% - 120%” is acceptable - or why I told my daughter she needed to insist on the brand thyroid meds (since switch to generic caused problems).
Generics are great and equivalent but not always equal, and yes, huge amounts manufactured in India.
[QUOTE=MaybeMorgan;7861123]
I’m not as familiar with animal med as human - human docs can absolutely prescribe off-label; the manufacturer cannot promote off-label use.
different for vets?
And my understanding of generic meds for humans is “80% - 120%” is acceptable - or why I told my daughter she needed to insist on the brand thyroid meds (since switch to generic caused problems).
Generics are great and equivalent but not always equal, and yes, huge amounts manufactured in India.[/QUOTE]
Veterinarians can prescribe off label, but only in certain circumstances. If there was no approved omeprazole product approved for horses, you could prescribe a human generic for a horse, but that is not the case. There is an approved product, so unless you have a really good reason for not prescribing that product (price is NOt considered a good reason), you have to prescribe that product.
Someone mentioned the previcox,/Equiox issue… same thing applies. A veterinarian can NOT prescribe previcox for a horse…
The thing about generics, is that you can’t just make some drug and sell it generic, you have to follow guidelines, and processes and get your generic approved… cheaper of course than typical drug development because you don’t need to do an efficacy trial. You just have to show equivalence. But you do have to do those studies. So the abler products aren’t even approved generics, they are just counterfeit drugs… no oversight at all…
I assume this also includes pentosan products sold on Prerace? Never bought from there, but saw the other day they sold those products and I wonder how they are able to do so…
So to be clear, the warning letter is telling the companies such as Abler that what they are doing (e.g. selling Abprazole) is illegal. As consumers, are we also breaking the law if we purchase products from the warned companies?
The Abler products are not counterfeit. They are not trying to pass them off as the name brand. They are simply unapproved.
A bit confused… So, side by side, how much of a difference is there between the amount of omeprazole in a tube of Gastrogard paste, and the amount of omeprazole in a tube of Abgard paste?
Ulcergard label = 37% w/w
Abgard label = 37% w/w
According to the FDA warning letter, Abgard “was found to be super-potent at 111.3% of the label claim for potency.”
[QUOTE=Iride;7871360]
A bit confused… So, side by side, how much of a difference is there between the amount of omeprazole in a tube of Gastrogard paste, and the amount of omeprazole in a tube of Abgard paste?[/QUOTE]
Abgard would have 2.53 grams omeprazole per tube versus 2.28 grams in gastrogard, so .25 g more.
So that is about 41% omeprazole in a tube vs. 37%
I have read most of the thread and feel the need to comment. I work for the FDA. I deal with food, not drugs.
All drugs go through the same approval process. Foreign companies get inspections from FDA too. Every week there are tons of trips to places like China and India. People from my office have gone on these trips to do the inspections. I have gone overseas for food inspections.
Warning Letters are just that, a warning. It does not mean they cannot produce. But depending on the way things are written they may not be able to produce until the issue is fixed.
As far as supplements, CFR 21 part 111 covers the regulations for supplements. A lot of companies are still not following the regs. They are getting punished too. I am not sure about animal supplements as I have not come across them in my work.
Labeling claims are a big deal. The wording can make it a drug or not. Ingredients can make it a drug or not. Some ingredients are drugs no matter what. We find a lot of unapproved drugs in products coming in from other countries.
Inspection happen on a routine basis. I am not sure about the drug companies but firms are scheduled based on risk and inspection history.
We are trying our best to make all food, drugs, devices, etc safe for humans and animals. It is hard with all the red tape we deal with because of the laws made years ago.
With the new FSMA rules (food safety modernization act), we will see more regulations just for animal feeds and such.
I am not on the forum much so if you ask a question I may not see it for a while. I hope I helped answer some questions.
Abler site is not working for me today. Anybody else have this problem?
You can try to put things in the cart, but it still says cart empty, and when I delete my cookies it is like the site is down completely.
[QUOTE=quikchik;7880745]
Abler site is not working for me today. Anybody else have this problem?
You can try to put things in the cart, but it still says cart empty, and when I delete my cookies it is like the site is down completely.[/QUOTE]
Yeah but it may be related to the above.
[QUOTE=CindyCRNA;7880792]
Yeah but it may be related to the above.[/QUOTE]
I figured, which is why I posted it in this thread. I just wanted to make sure it wasn’t just me.
[QUOTE=quikchik;7880798]
I figured, which is why I posted it in this thread. I just wanted to make sure it wasn’t just me.[/QUOTE]
So I called them today to see what was up with the site (and I have a $330 order I just placed!) but it went to voice mail and I decided to not leave a message. While I was out riding, they returned my call 3 times and left a message. I called back to ask about the site (call was to Alberta Canada but the lady didn’t sound Canadian, Lol!). She said it would be back up. When I told her that her product was popular, she said they were having almost record sales as of recent. She was also proud they had tested to 111% and I said I was too! :winkgrin:
Thanks for the update! It is up now.
[QUOTE=quikchik;7884832]
Thanks for the update! It is up now.[/QUOTE]
Also, the same day, they sent me current tracking info and it is due to arrive today or tomorrow.
I just received my order yesterday. It was labeled as a equine supplement with a value of $12 for customs. It came through NY customs I think.
I emailed Abler to ask whether they are still shipping to the USA after the FDA warning letter, and whether or not they are applying for registration in the USA, and this is the reply I got:
Hi Patricia,
Buiness as usual at Abler. Yes we are in the process of registration in Usa.
Look forwrd to your order.
Julia
[QUOTE=dogbluehorse;7896343]
I emailed Abler to ask whether they are still shipping to the USA after the FDA warning letter, and whether or not they are applying for registration in the USA, and this is the reply I got:
Hi Patricia,
Buiness as usual at Abler. Yes we are in the process of registration in Usa.
Look forwrd to your order.
Julia[/QUOTE]
I received my order this week.
Has anyone ever had Abler’s blue pop rocks NOT work for their horse?
Just wondering cuz I am having such an issue with my guy…
(I have a post under horse care regarding…)
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