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Hungarian Midget Woman
  
Location: Midwest | Tuesday, November 4, 2014 Print
FDA: Equine Ulcer Product Marketing Leads to Warnings for Horse Companies
stock photo by RMHP Staff, The U.S. Food and Drug Administration sent warning letters to equine companies who are allegedly marketing their horse ulcer products without federal approval. The FDA sent warning letters to three Florida based companies: Horse Gold, Inc., Horse PreRace, and Tri-Star Equine Marketing. The companies are accused by the government agency of marketing gastric ulcer products as "intended for the use in the mitigation, treatment, or prevention of disease in animals," which under the law makes their products a drug. The warning letters state "to be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing..." The FDA states the companies' drugs are considered unsafe and adulterated. HorseGold, Inc. markets the product GastroMax3. Click here to read the company's warning letter. Horse PreRace markets several products including Omeprazole Oral Paste, Omeprazole/Ranitidine Oral Paste, Gastrotec, Gastromax3, Flunixin, Synedem, Toltrazuril Paste, and Super Tie Up. Click here to read the warning letter. Tri-Star Equine Marketing promotes the product Gastrotec.Click here to read the company's warning letter. The companies have 15 days to respond to the FDA regarding their compliance.
Edited by barrelracr131 2014-11-05 10:32 AM
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Hungarian Midget Woman
Location: Midwest | In other words, the FDA is trying to stop these companies from selling Ulcerguard/Gastrogard (from what I can tell) ETA: Should have said "generic compunded omneprazole", not UG/GG
Edited by barrelracr131 2014-11-05 11:02 AM
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 Tough Patooty
Posts: 2615
Location: Sperry, OK | 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? |
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Hungarian Midget Woman
Location: Midwest | 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. |
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Tough Patooty
Posts: 2615
Location: Sperry, OK | barrelracr131 - 2014-11-05 10:40 AM In other words, the FDA is trying to stop these companies from selling Ulcerguard/Gastrogard (from what I can tell)
These companies aren't actually selling Ulcergard/Gastrogard. They are selling Omeprozole (and others like it), but the hang up is the claims they make to treat/cure/prevent ulcers. This is where they get in trouble. The mechanism that allows Ulcergard/Gastrogard to make it past the acid in the stomach, to get absorbed to be able to shut down the proton pumps that produce the acid is patented by Merial. To get that patent and FDA approval, Merial had to go through years of testing and millions of dollars for testing... These other products don't use the same mechanism and have not gone through the testing to get approval from the FDA, so therfore, they can not make the claim on the label they are making and it be legal.
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Tough Patooty
Posts: 2615
Location: Sperry, OK | 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.
Edited by ACEINTHEHOLE 2014-11-05 10:54 AM
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 Extreme Veteran
Posts: 554
| Oh don't worry he will be in prison soon, and I bet the FDA won't be able to find him.  |
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Extreme Veteran
Posts: 330
| 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/ |
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Hungarian Midget Woman
Location: Midwest | 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.
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. |
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Hungarian Midget Woman
Location: Midwest | 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. |
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Hungarian Midget Woman
Location: Midwest | rowdy256 - 2014-11-05 10:55 AM Oh don't worry he will be in prison soon, and I bet the FDA won't be able to find him.
Or LRQHs will have locked him up in her basement |
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 Elite Veteran
Posts: 972
Location: Texas! | 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. |
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Extreme Veteran
Posts: 330
| 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. |
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Extreme Veteran
Posts: 554
| barrelracr131 - 2014-11-05 11:02 AM
rowdy256 - 2014-11-05 10:55 AM Oh don't worry he will be in prison soon, and I bet the FDA won't be able to find him.
Good one, or locked in her barn! |
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Extreme Veteran
Posts: 330
| 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/
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. |
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 BHW's Lance Armstrong 
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Location: Somewhere between S@%&# stirrer and Saint | 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? Yes, I will comment later. Where was the FDA when SUPERIORBUTE POWDER was being produced and all the illegal compounders were out there mass producing?
Edited by Douglas J Gordon 2014-11-05 11:14 AM
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Hungarian Midget Woman
Location: Midwest | 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... |
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Tough Patooty
Posts: 2615
Location: Sperry, OK | 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/
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.
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Hungarian Midget Woman
Location: Midwest | 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/
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.
Agree-
Honestly I'm not sure of the buffers in these various products. |
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Tough Patooty
Posts: 2615
Location: Sperry, OK | 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.
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! |
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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/
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.
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/
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.
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/
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.
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) 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/
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.
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?
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.
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/
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.
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? 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.
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.
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.
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'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.
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'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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Tough Patooty
Posts: 2615
Location: Sperry, OK | ChicksInferno - 2014-11-05 3:30 PM 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.
Where do you buy it that it cost $35 tube? Ouch!
Do you realize how much money they have tied up in the process of researching to find a carrier that will stay intact through the acid in the stomach, formulating that to find the right mixure.. to be effective but not overly effective so it will get absorbed, then in house research to find the dosage amount to be effective once admistered to the horse to treat/cure the ulcers, then the FDA testing required? I for sure understand their stance on price, considering they only have a certain time frame to recoup money before the patent runs out and gernerics can be made.
I also understand us poor folks trying to buy it, but they don't have it priced that way just to gouge us.
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Member
Posts: 29
| Extra-Label Drug Use (ELDU):
"ELDU describes the use of an approved drug in a manner that is not in accordance with the approved labeling, yet meets the conditions set forth by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and U.S. Food and Drug Administration (FDA) regulations. Deviations from FDA-approved labeling include use in another species, use for a different indication, use at a different dose or frequency, and use via a different route of administration."
https://www.avma.org/KB/Resources/FAQs/Pages/ELDU-and-AMDUCA-FAQs.as...
The issue I see here is the claim to treat or prevent a medical condition. Simple solution: change the claims made by the drug manufacturers. It just happened in our town with a company that makes human nutraceuticals. They went too far on their claims and were told to back off by the FDA. Once they did, they were back in production.
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 Banjo and Baby
Posts: 7259
Location: South of Canada and North of Mexico | ChicksInferno - 2014-11-05 3:30 PM 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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Extreme Veteran
Posts: 330
| ChicksInferno - 2014-11-05 4:30 PM
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.
THIS! I actually just said this SAME thing to my vet this morning while discussing this FDA warning. |
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 Husband Spoiler
Posts: 4151
Location: North Dakota | 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.
That is why you read the ingredients and compare. I never just go by what the product is advertised as. I read the ingredients and learn about what is in the product and why the product does what is says it does. |
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Extreme Veteran
Posts: 330
| Just Bring It - 2014-11-06 9:16 AM 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.
Which is all well and good that you read the ingredients - but that's exactly what this is about...with products that are not FDA approved, what the label says and what is ACTUALLY in the product are not always the same. |
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  Warmblood with Wings
Posts: 27846
Location: Florida.. | SuckerForHorses - 2014-11-06 9:23 AM Just Bring It - 2014-11-06 9:16 AM 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. Which is all well and good that you read the ingredients - but that's exactly what this is about...with products that are not FDA approved, what the label says and what is ACTUALLY in the product are not always the same.
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 Famous for Not Complaining
Posts: 8848
Location: Broxton, Ga | ACEINTHEHOLE - 2014-11-04 5:14 PM ChicksInferno - 2014-11-05 3:30 PM 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. Where do you buy it that it cost $35 tube? Ouch!
Do you realize how much money they have tied up in the process of researching to find a carrier that will stay intact through the acid in the stomach, formulating that to find the right mixure.. to be effective but not overly effective so it will get absorbed, then in house research to find the dosage amount to be effective once admistered to the horse to treat/cure the ulcers, then the FDA testing required? I for sure understand their stance on price, considering they only have a certain time frame to recoup money before the patent runs out and gernerics can be made.
I also understand us poor folks trying to buy it, but they don't have it priced that way just to gouge us.
Patents are not cheap either..........unless one has done one you have no clue.......then there is just the cost of the patent maintenance.........that's where we should complain as to the government ripping off companies just because they can..........but I do agree the stuff is HIGH! |
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BHW's Lance Armstrong
Posts: 11134
Location: Somewhere between S@%&# stirrer and Saint | ACEINTHEHOLE - 2014-11-05 4:14 PM ChicksInferno - 2014-11-05 3:30 PM 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. Where do you buy it that it cost $35 tube? Ouch!
Do you realize how much money they have tied up in the process of researching to find a carrier that will stay intact through the acid in the stomach, formulating that to find the right mixure.. to be effective but not overly effective so it will get absorbed, then in house research to find the dosage amount to be effective once admistered to the horse to treat/cure the ulcers, then the FDA testing required? I for sure understand their stance on price, considering they only have a certain time frame to recoup money before the patent runs out and gernerics can be made.
I also understand us poor folks trying to buy it, but they don't have it priced that way just to gouge us.
ACEINTHEHOLE you are preaching what I was preaching about 8 years ago on here about illegal compounded bute and the ladies chewed my ass up and spit me out. Yep we all spend tons of money to get a drug FDA approved (SUPERIORBUTE POWDER) problem was the vets weren't ethical enough to support it. I have loyal customers but not enough of them. Maybe the FDA is actually doing something. |
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Tough Patooty
Posts: 2615
Location: Sperry, OK | Douglas J Gordon - 2014-11-06 10:57 AM ACEINTHEHOLE - 2014-11-05 4:14 PM ChicksInferno - 2014-11-05 3:30 PM 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. Where do you buy it that it cost $35 tube? Ouch!
Do you realize how much money they have tied up in the process of researching to find a carrier that will stay intact through the acid in the stomach, formulating that to find the right mixure.. to be effective but not overly effective so it will get absorbed, then in house research to find the dosage amount to be effective once admistered to the horse to treat/cure the ulcers, then the FDA testing required? I for sure understand their stance on price, considering they only have a certain time frame to recoup money before the patent runs out and gernerics can be made.
I also understand us poor folks trying to buy it, but they don't have it priced that way just to gouge us.
DJG, I am sorry you got chewed up and spit out.. LOL.. I can recall that name, so I am pretty sure I ordered it when I was working for the Equine clinic here in OK... I was the head tech and in charge of all orders and stocking the pharmacy. I supported you Doug! Anyway.. once I went through tech school and learned the laws and regulation on things.. It for sure opened my eyes to a whole new world! |
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FDA Ulcer Med Crackdown- just a head's up to those who order generic Omneprazole!
