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Hungarian Midget Woman
    Location: Midwest | ACEINTHEHOLE - 2014-11-05 11:14 AM barrelracr131 - 2014-11-05 11:01 AM SuckerForHorses - 2014-11-05 10:56 AM barrelracr131 - 2014-11-05 11:40 AM In other words, the FDA is trying to stop these companies from selling Ulcerguard/Gastrogard (from what I can tell) That's not what the letter says at all. It has NOTHING to do with Merial's UlcerGard or GastroGard.
The warning is because the products they are selling aren't FDA approved for the use that they are marketing them for. Also, an interesting note:
Further, the letter to Jones stated that the FDA had obtained samples of the company’s Omeprazole Oral Paste, which is designed to alleviate symptoms associated with gastric ulcers. The amount of the active ingredient (omeprazole) detected in the samples was less than that claimed on the product’s label–just 68.1 percent of the label claim, to be exact–which also puts it in violation of federal law.
http://www.paulickreport.com/news/the-biz/fda-issues-warning-letters-to-horse-supplement-companies/ Yes, you are correct- that should say "generic omneprazole", not the specific product name.
and you are correct on the lowered efficacy... however, the costs between the two products are VASTLY different.
I realize much of the hoopla is based upon the "claims" made by the companies, but I mostly wanted to warn people that these products mentioned might not be available in the future. You can't have a "generic ulcergard" when the patend on Ulcergard has not expired. And you, by law, can not prescribe a drug for off label use when there is a drug on the market for that specific use. Years ago when vets prescribed all the human pills for ulcers, pepto type stuff for ulcers, etc.. they could do that legally since there was not an FDA approved drug on the market specifically for ulcers. Now that Ulcergard/Gastrogard is on the market, it is ILLEGAL for vets to prescribe human/dog approved opmeprozole (or any other one out there) for use in horses. I know they do it, but if they were to get caught, it would for sure be a hefty fine and possibly their license.
I was under the impression that they were able to do off-label prescriptions if the FDA approved form was a problem for administration to a specific animal.
For example, prescribing a non-FDA approved pill for a horse when the horse cannot handle the administration of the FDA approved paste version.
Is that incorrect? | |
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 Tough Patooty
Posts: 2615
   Location: Sperry, OK | SuckerForHorses - 2014-11-05 11:12 AM barrelracr131 - 2014-11-05 12:01 PM SuckerForHorses - 2014-11-05 10:56 AM barrelracr131 - 2014-11-05 11:40 AM In other words, the FDA is trying to stop these companies from selling Ulcerguard/Gastrogard (from what I can tell) That's not what the letter says at all. It has NOTHING to do with Merial's UlcerGard or GastroGard.
The warning is because the products they are selling aren't FDA approved for the use that they are marketing them for. Also, an interesting note:
Further, the letter to Jones stated that the FDA had obtained samples of the company’s Omeprazole Oral Paste, which is designed to alleviate symptoms associated with gastric ulcers. The amount of the active ingredient (omeprazole) detected in the samples was less than that claimed on the product’s label–just 68.1 percent of the label claim, to be exact–which also puts it in violation of federal law.
http://www.paulickreport.com/news/the-biz/fda-issues-warning-letters-to-horse-supplement-companies/ Yes, you are correct- that should say "generic omneprazole", not the specific product name.
and you are correct on the lowered efficacy... however, the costs between the two products are VASTLY different.
I realize much of the hoopla is based upon the "claims" made by the companies, but I mostly wanted to warn people that these products mentioned might not be available in the future. What we also don't know, is if the delivery is effective with the other pastes like it is with UlcerGard and GastroGard.
If these generics do not have a buffering ingredient to prevent degradation of the omeprazole in the stomach, it doesn't really matter how much or little omeprazole is in the tube if it doesn't reach its desired location to start working properly.
You are exactly right.. and most don't do a darned thing, some do very little.. some do more. There is no regulation and no guarantee. That is the issue. | |
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Hungarian Midget Woman
    Location: Midwest | ACEINTHEHOLE - 2014-11-05 11:15 AM barrelracr131 - 2014-11-05 11:13 AM SuckerForHorses - 2014-11-05 11:10 AM WYOracer - 2014-11-05 12:07 PM They are in trouble for the claims of preventing or treating ulcers is the way I read it. That's what makes it a "drug" and the need for FDA approval. Yes. Correct- so I am questioning how they will be able to continue to sell this product in the future... By law, they can't.. that is the issue and why they are cracking down.. all this per Merial's request btw.. I have a good friend that is a rep for them, they report these companies daily!
I certainly understand why they do... the costs they have in research is extremely high. | |
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 Tough Patooty
Posts: 2615
   Location: Sperry, OK | barrelracr131 - 2014-11-05 11:17 AM ACEINTHEHOLE - 2014-11-05 11:14 AM barrelracr131 - 2014-11-05 11:01 AM SuckerForHorses - 2014-11-05 10:56 AM barrelracr131 - 2014-11-05 11:40 AM In other words, the FDA is trying to stop these companies from selling Ulcerguard/Gastrogard (from what I can tell) That's not what the letter says at all. It has NOTHING to do with Merial's UlcerGard or GastroGard.
The warning is because the products they are selling aren't FDA approved for the use that they are marketing them for. Also, an interesting note:
Further, the letter to Jones stated that the FDA had obtained samples of the company’s Omeprazole Oral Paste, which is designed to alleviate symptoms associated with gastric ulcers. The amount of the active ingredient (omeprazole) detected in the samples was less than that claimed on the product’s label–just 68.1 percent of the label claim, to be exact–which also puts it in violation of federal law.
http://www.paulickreport.com/news/the-biz/fda-issues-warning-letters-to-horse-supplement-companies/ Yes, you are correct- that should say "generic omneprazole", not the specific product name.
and you are correct on the lowered efficacy... however, the costs between the two products are VASTLY different.
I realize much of the hoopla is based upon the "claims" made by the companies, but I mostly wanted to warn people that these products mentioned might not be available in the future. You can't have a "generic ulcergard" when the patend on Ulcergard has not expired. And you, by law, can not prescribe a drug for off label use when there is a drug on the market for that specific use. Years ago when vets prescribed all the human pills for ulcers, pepto type stuff for ulcers, etc.. they could do that legally since there was not an FDA approved drug on the market specifically for ulcers. Now that Ulcergard/Gastrogard is on the market, it is ILLEGAL for vets to prescribe human/dog approved opmeprozole (or any other one out there) for use in horses. I know they do it, but if they were to get caught, it would for sure be a hefty fine and possibly their license.
I was under the impression that they were able to do off-label prescriptions if the FDA approved form was a problem for administration to a specific animal.
For example, prescribing a non-FDA approved pill for a horse when the horse cannot handle the administration of the FDA approved paste version.
Is that incorrect?
That is incorrect. As long as there is an approved product on the market, they can't prescripe off label use legally. | |
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Extreme Veteran
Posts: 330
   
| ACEINTHEHOLE - 2014-11-05 12:19 PM
barrelracr131 - 2014-11-05 11:17 AM ACEINTHEHOLE - 2014-11-05 11:14 AM barrelracr131 - 2014-11-05 11:01 AM SuckerForHorses - 2014-11-05 10:56 AM barrelracr131 - 2014-11-05 11:40 AM In other words, the FDA is trying to stop these companies from selling Ulcerguard/Gastrogard (from what I can tell)Â That's not what the letter says at all. It has NOTHING to do with Merial's UlcerGard or GastroGard.
The warning is because the products they are selling aren't FDA approved for the use that they are marketing them for. Also, an interesting note:
Further, the letter to Jones stated that the FDA had obtained samples of the company’s Omeprazole Oral Paste, which is designed to alleviate symptoms associated with gastric ulcers. The amount of the active ingredient (omeprazole) detected in the samples was less than that claimed on the product’s label–just 68.1 percent of the label claim, to be exact–which also puts it in violation of federal law.
http://www.paulickreport.com/news/the-biz/fda-issues-warning-letters-to-horse-supplement-companies/ Yes, you are correct- that should say "generic omneprazole", not the specific product name.
and you are correct on the lowered efficacy... however, the costs between the two products are VASTLY different.
I realize much of the hoopla is based upon the "claims" made by the companies, but I mostly wanted to warn people that these products mentioned might not be available in the future. You can't have a "generic ulcergard" when the patend on Ulcergard has not expired.  And you, by law, can not prescribe a drug for off label use when there is a drug on the market for that specific use.   Years ago when vets prescribed all the human pills for ulcers, pepto type stuff for ulcers, etc.. they could do that legally since there was not an FDA approved drug on the market specifically for ulcers.  Now that Ulcergard/Gastrogard is on the market, it is ILLEGAL for vets to prescribe human/dog approved opmeprozole (or any other one out there) for use in horses.  I know they do it, but if they were to get caught, it would for sure be a hefty fine and possibly their license.
 I was under the impression that they were able to do off-label prescriptions if the FDA approved form was a problem for administration to a specific animal.
For example, prescribing a non-FDA approved pill for a horse when the horse cannot handle the administration of the FDA approved paste version.
Is that incorrect?Â
That is incorrect. Â As long as there is an approved product on the market, they can't prescripe off label use legally.Â
Same thing with vets prescribing previcox (the dog tablets) for horses. They shouldn't be doing that either, because there is an approved version of the drug firocoxib, called Equioxx, which is for horses. | |
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 Tough Patooty
Posts: 2615
   Location: Sperry, OK | barrelracr131 - 2014-11-05 10:58 AM ACEINTHEHOLE - 2014-11-05 10:52 AM barrelracr131 - 2014-11-05 10:46 AM ACEINTHEHOLE - 2014-11-05 10:42 AM Douglas J Gordon, does this type of FDA crackdown affect you? I know you are not listed in this particular group, but does your product get affected by this type of issue? His would perhaps be exempt because it is a powder, but I'm not 100% sure. It doesn't matter the form, it matters on what testing and FDA approval rec'd based on the claims made on the label. I may be wrong, but I think you have to gain approval from the FDA through testing for each claim (possibly each form of product, i.e. paste, injectable, powder, etc.) made. That is why they have to package the Ulcergard different from the Gastrogard and have different labeling instructions. One was tested and approved for treatment and one for maintenance. Even though it is the same product, same dosage and same quantity in the tube, they had to test each one seperately since each had its own claim.
My guess is the difference between GG/UG is in the manufacturing procedures. For it to be FDA approved, the manufacturing process is part of the approval, as well as certain quality control measures.
I'm guessing they started selling the Ulcerguard as a cheaper alternative once they found a cheaper way to make the product. If they change anything during the manufacturing process, they would have to redo all of the clinical trials and research. (way too expensive).
I'm only familiar with FDA approval in a medical test context so I could be wrong about some specifics.
That is incorrect. They tested them at the same time. Per the FDA, they could not test one product for treatment AND prevention, as those are two seperate claims. So they had to package and label each one seperately and have them tested based on the claims made on the package. You can buy either one to treat or to maintain... as they are the EXACT same product. But by FDA regulations, to make both claims, they had to be their own product in labeling and directions for use. | |
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 Tough Patooty
Posts: 2615
   Location: Sperry, OK | SuckerForHorses - 2014-11-05 11:21 AM ACEINTHEHOLE - 2014-11-05 12:19 PM barrelracr131 - 2014-11-05 11:17 AM ACEINTHEHOLE - 2014-11-05 11:14 AM barrelracr131 - 2014-11-05 11:01 AM SuckerForHorses - 2014-11-05 10:56 AM barrelracr131 - 2014-11-05 11:40 AM In other words, the FDA is trying to stop these companies from selling Ulcerguard/Gastrogard (from what I can tell) That's not what the letter says at all. It has NOTHING to do with Merial's UlcerGard or GastroGard.
The warning is because the products they are selling aren't FDA approved for the use that they are marketing them for. Also, an interesting note:
Further, the letter to Jones stated that the FDA had obtained samples of the company’s Omeprazole Oral Paste, which is designed to alleviate symptoms associated with gastric ulcers. The amount of the active ingredient (omeprazole) detected in the samples was less than that claimed on the product’s label–just 68.1 percent of the label claim, to be exact–which also puts it in violation of federal law.
http://www.paulickreport.com/news/the-biz/fda-issues-warning-letters-to-horse-supplement-companies/ Yes, you are correct- that should say "generic omneprazole", not the specific product name.
and you are correct on the lowered efficacy... however, the costs between the two products are VASTLY different.
I realize much of the hoopla is based upon the "claims" made by the companies, but I mostly wanted to warn people that these products mentioned might not be available in the future. You can't have a "generic ulcergard" when the patend on Ulcergard has not expired. And you, by law, can not prescribe a drug for off label use when there is a drug on the market for that specific use. Years ago when vets prescribed all the human pills for ulcers, pepto type stuff for ulcers, etc.. they could do that legally since there was not an FDA approved drug on the market specifically for ulcers. Now that Ulcergard/Gastrogard is on the market, it is ILLEGAL for vets to prescribe human/dog approved opmeprozole (or any other one out there) for use in horses. I know they do it, but if they were to get caught, it would for sure be a hefty fine and possibly their license.
I was under the impression that they were able to do off-label prescriptions if the FDA approved form was a problem for administration to a specific animal.
For example, prescribing a non-FDA approved pill for a horse when the horse cannot handle the administration of the FDA approved paste version.
Is that incorrect? That is incorrect. As long as there is an approved product on the market, they can't prescripe off label use legally. Same thing with vets prescribing previcox (the dog tablets ) for horses. They shouldn't be doing that either, because there is an approved version of the drug firocoxib, called Equioxx, which is for horses.
Exactly! | |
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Hungarian Midget Woman
    Location: Midwest | Well thanks for answering my questions ladies!
I actually have used the off brands in the past with decent results. I know others have in the past as well, so I figured I would share this as folks may need to find another option in the future | |
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 Tough Patooty
Posts: 2615
   Location: Sperry, OK | barrelracr131 - 2014-11-05 11:18 AM ACEINTHEHOLE - 2014-11-05 11:15 AM barrelracr131 - 2014-11-05 11:13 AM SuckerForHorses - 2014-11-05 11:10 AM WYOracer - 2014-11-05 12:07 PM They are in trouble for the claims of preventing or treating ulcers is the way I read it. That's what makes it a "drug" and the need for FDA approval. Yes. Correct- so I am questioning how they will be able to continue to sell this product in the future... By law, they can't.. that is the issue and why they are cracking down.. all this per Merial's request btw.. I have a good friend that is a rep for them, they report these companies daily! I certainly understand why they do... the costs they have in research is extremely high. I am on both sides of this... I, as a horse owner and a poor working girl, really like the idea of the cheaper products and off-label drug use. But, I, as an educated (took vows to uphold laws and animal rights) vet tech, for sure understand the legallity of it all, and the money invested in these drugs. I appreciate the expense the drug companies go through to get us these drugs to use, as animal medicine has closed a vast gap in quality over the last few years. We now have hope where there was none before... for me, it's a catch 22. But for companies like Merial, it is very cut and dry.
Edited by ACEINTHEHOLE 2014-11-05 12:03 PM
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Hungarian Midget Woman
    Location: Midwest | For Merial, yeah, there is no question. Legally they have every right to close the hole in the market! As a horse owner, I just hate to see the cheap options go away.... lol | |
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Expert
Posts: 2531
   Location: WI | Can't the companies that received this letter just change the claim to something like 'promotes digestive health' like all the other ulcer supplements out there? As far as I can tell, this is more of a marketing issue that a generic drug issue. | |
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 Tough Patooty
Posts: 2615
   Location: Sperry, OK | linds - 2014-11-05 12:09 PM Can't the companies that received this letter just change the claim to something like 'promotes digestive health' like all the other ulcer supplements out there? As far as I can tell, this is more of a marketing issue that a generic drug issue.
Maybe, but then how does one of these companies get the attention of the ulcer treater by saying "digestive health". If I was reading that, I would think it was like a probiotic or something that just helped my horse to better utilize their feed/forage, not treat for ulcers. | |
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Expert
Posts: 2531
   Location: WI | ACEINTHEHOLE - 2014-11-05 12:27 PM linds - 2014-11-05 12:09 PM Can't the companies that received this letter just change the claim to something like 'promotes digestive health' like all the other ulcer supplements out there? As far as I can tell, this is more of a marketing issue that a generic drug issue. Maybe, but then how does one of these companies get the attention of the ulcer treater by saying "digestive health". If I was reading that, I would think it was like a probiotic or something that just helped my horse to better utilize their feed/forage, not treat for ulcers.
I actually copied that on the description of U7 Gastric Aid. They don't mention ulcers at all in their description, but I think we all know people use it for ulcer maintenance on horses. It's all about marketing!!
U-7 Gastric Aid Liquid by Finish Line is an easy-to-use dietary supplement that promotes digestive health. It can help horses that suffer from poor appetite, poor attitude, dull coat or reduced performance. | |
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Hungarian Midget Woman
    Location: Midwest | linds - 2014-11-05 1:09 PM ACEINTHEHOLE - 2014-11-05 12:27 PM linds - 2014-11-05 12:09 PM Can't the companies that received this letter just change the claim to something like 'promotes digestive health' like all the other ulcer supplements out there? As far as I can tell, this is more of a marketing issue that a generic drug issue. Maybe, but then how does one of these companies get the attention of the ulcer treater by saying "digestive health". If I was reading that, I would think it was like a probiotic or something that just helped my horse to better utilize their feed/forage, not treat for ulcers. I actually copied that on the description of U7 Gastric Aid. They don't mention ulcers at all in their description, but I think we all know people use it for ulcer maintenance on horses. It's all about marketing!!
U-7 Gastric Aid Liquid by Finish Line is an easy-to-use dietary supplement that promotes digestive health. It can help horses that suffer from poor appetite, poor attitude, dull coat or reduced performance.
I would guess the use of Omneprazole in horses might be part of the whole patent? | |
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Expert
Posts: 2531
   Location: WI | barrelracr131 - 2014-11-05 1:17 PM
linds - 2014-11-05 1:09 PM ACEINTHEHOLE - 2014-11-05 12:27 PM linds - 2014-11-05 12:09 PM Can't the companies that received this letter just change the claim to something like 'promotes digestive health' like all the other ulcer supplements out there?  As far as I can tell, this is more of a marketing issue that a generic drug issue. Maybe, but then how does one of these companies get the attention of the ulcer treater by saying "digestive health".  If I was reading that, I would think it was like a probiotic or something that just helped my horse to better utilize their feed/forage, not treat for ulcers. I actually copied that on the description of U7 Gastric Aid.  They don't mention ulcers at all in their description, but I think we all know people use it for ulcer maintenance on horses.  It's all about marketing!!
U-7 Gastric Aid Liquid by Finish Line is an easy-to-use dietary supplement that promotes digestive health. It can help horses that suffer from poor appetite, poor attitude, dull coat or reduced performance. Â
I would guess the use of Omneprazole in horses might be part of the whole patent?Â
I'm pretty sure the patent has to do with the carrier and formula, not with the drug.
There are a lot of compounding pharmacies that sell omeprazole and they did not get these letters - because they are not advertising that their products treat or prevent ulcers. They don't advertise. | |
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 Big Gun
Posts: 2216
   Location: Texas | Has anyone used the gastro max plus over ulcer guard? | |
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Hungarian Midget Woman
    Location: Midwest | linds - 2014-11-05 2:19 PM barrelracr131 - 2014-11-05 1:17 PM linds - 2014-11-05 1:09 PM ACEINTHEHOLE - 2014-11-05 12:27 PM linds - 2014-11-05 12:09 PM Can't the companies that received this letter just change the claim to something like 'promotes digestive health' like all the other ulcer supplements out there? As far as I can tell, this is more of a marketing issue that a generic drug issue. Maybe, but then how does one of these companies get the attention of the ulcer treater by saying "digestive health". If I was reading that, I would think it was like a probiotic or something that just helped my horse to better utilize their feed/forage, not treat for ulcers. I actually copied that on the description of U7 Gastric Aid. They don't mention ulcers at all in their description, but I think we all know people use it for ulcer maintenance on horses. It's all about marketing!!
U-7 Gastric Aid Liquid by Finish Line is an easy-to-use dietary supplement that promotes digestive health. It can help horses that suffer from poor appetite, poor attitude, dull coat or reduced performance. I would guess the use of Omneprazole in horses might be part of the whole patent? I'm pretty sure the patent has to do with the carrier and formula, not with the drug. There are a lot of compounding pharmacies that sell omeprazole and they did not get these letters - because they are not advertising that their products treat or prevent ulcers. They don't advertise.
Gotcha | |
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 BHW's Lance Armstrong 
Posts: 11134
     Location: Somewhere between S@% stirrer and Saint | linds - 2014-11-05 12:09 PM Can't the companies that received this letter just change the claim to something like 'promotes digestive health' like all the other ulcer supplements out there? As far as I can tell, this is more of a marketing issue that a generic drug issue.
Bingo! | |
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 Expert
Posts: 5293
     
| So now I will be looking for " Promotes Digestive Health OTC"  | |
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Extreme Veteran
Posts: 300
  
| I wish Merial would realize if they dropped the price more on their product they would probably sell more of it. Really who can afford to treat their horse for 30 days with a product that costs $35/tube. Thats more than what I make in a month! They are missing a huge horse population that wants to do whats best for their horses but are ruled by their income. | |
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