Viokase is not being made anymore

[izemmom]

But even after approval, there will no longer be powder, right?
<br />
<br />And, didn't someone say something on here once that it was beign discontinued due to a machine used in the production process being put out of service?!?! Seems pretty ricidulous to me, but I could swear that's what I read! LOL!

 

[hmw]

Yeah... it's my understanding the Viokase powdered enzymes were discontinued even before the fda deadline.

That August 31st thing really bothers me. Who knows how long it will even take after *that* before they are available on the market...? The Q&A said that they submitted everything they needed to on time... argh. Hopefully they release more info soon about the letter they received about Ultrase and THAT won't be Aug 31st too.

It really bothers me that this FDA backlog is affecting the enzymes that work best with g-tubes from being available to those that need them. <img src="i/expressions/face-icon-small-mad.gif" border="0">

 

[hmw]

Yeah... it's my understanding the Viokase powdered enzymes were discontinued even before the fda deadline.

That August 31st thing really bothers me. Who knows how long it will even take after *that* before they are available on the market...? The Q&A said that they submitted everything they needed to on time... argh. Hopefully they release more info soon about the letter they received about Ultrase and THAT won't be Aug 31st too.

It really bothers me that this FDA backlog is affecting the enzymes that work best with g-tubes from being available to those that need them. <img src="i/expressions/face-icon-small-mad.gif" border="0">

 

[hmw]

Yeah... it's my understanding the Viokase powdered enzymes were discontinued even before the fda deadline.
<br />
<br />That August 31st thing really bothers me. Who knows how long it will even take after *that* before they are available on the market...? The Q&A said that they submitted everything they needed to on time... argh. Hopefully they release more info soon about the letter they received about Ultrase and THAT won't be Aug 31st too.
<br />
<br />It really bothers me that this FDA backlog is affecting the enzymes that work best with g-tubes from being available to those that need them. <img src="i/expressions/face-icon-small-mad.gif" border="0">

 

[crickit715]

there was a previous post a few months back on this same topic....you may want to check it out to get othere options besides the viokase!! good luck! im in the same boat! <img src="i/expressions/face-icon-small-smile.gif" border="0">

 

[crickit715]

there was a previous post a few months back on this same topic....you may want to check it out to get othere options besides the viokase!! good luck! im in the same boat! <img src="i/expressions/face-icon-small-smile.gif" border="0">

 

[crickit715]

there was a previous post a few months back on this same topic....you may want to check it out to get othere options besides the viokase!! good luck! im in the same boat! <img src="i/expressions/face-icon-small-smile.gif" border="0">

 

[hmw]

Due to how many people are dependent on each of the various enzymes out there, I am SO hoping the Viokase tablets become available as soon as that Aug 30th review happens. Since the FDA refused to expedite the process involved in getting it approved it will be AT LEAST 8/30/10 before anything further happens in this process, and it's frustrating because Axcan did their part and submitted everything on time.

And about Ultrase; something new dated 5/6/10

<a target=_blank class=ftalternatingbarlinklarge href="http://www.axcan.com/patient_product_update.php?lang=1">Ultrase: product update; Axcan website</a>

In short, it's application/whatever was reviewed and more needs to be done before it can gain FDA approval- although at least it doesn't need to go through more clinical trials.


The other enzyme people talked about on an old g-tube thread was, if I am remembering right, Pancrecarb... one of them (the 4's I think) came in tiny beads that could go through the tube easily. THAT one hasn't been FDA approved yet either... I hope that one becomes available a lot sooner than the Viokase. In the meantime, I am wondering how Emily's Creon is likely to work w/ the tube... and if we'll have to wake up during the night, etc etc.

It's frustrating that now finding solutions until FDA approval for these meds means making changes for many months, not some brief little time period like originally hoped for. <img src="i/expressions/face-icon-small-frown.gif" border="0">

This has been in the works since 2004... why did it have to come down to the wire like this and leave so many people in the lurch? It's not like they had to completely reinvent the things over the last 6 years or something... Sigh...

 

[hmw]

Due to how many people are dependent on each of the various enzymes out there, I am SO hoping the Viokase tablets become available as soon as that Aug 30th review happens. Since the FDA refused to expedite the process involved in getting it approved it will be AT LEAST 8/30/10 before anything further happens in this process, and it's frustrating because Axcan did their part and submitted everything on time.

And about Ultrase; something new dated 5/6/10

<a target=_blank class=ftalternatingbarlinklarge href="http://www.axcan.com/patient_product_update.php?lang=1">Ultrase: product update; Axcan website</a>

In short, it's application/whatever was reviewed and more needs to be done before it can gain FDA approval- although at least it doesn't need to go through more clinical trials.


The other enzyme people talked about on an old g-tube thread was, if I am remembering right, Pancrecarb... one of them (the 4's I think) came in tiny beads that could go through the tube easily. THAT one hasn't been FDA approved yet either... I hope that one becomes available a lot sooner than the Viokase. In the meantime, I am wondering how Emily's Creon is likely to work w/ the tube... and if we'll have to wake up during the night, etc etc.

It's frustrating that now finding solutions until FDA approval for these meds means making changes for many months, not some brief little time period like originally hoped for. <img src="i/expressions/face-icon-small-frown.gif" border="0">

This has been in the works since 2004... why did it have to come down to the wire like this and leave so many people in the lurch? It's not like they had to completely reinvent the things over the last 6 years or something... Sigh...

 

[hmw]

Due to how many people are dependent on each of the various enzymes out there, I am SO hoping the Viokase tablets become available as soon as that Aug 30th review happens. Since the FDA refused to expedite the process involved in getting it approved it will be AT LEAST 8/30/10 before anything further happens in this process, and it's frustrating because Axcan did their part and submitted everything on time.
<br />
<br />And about Ultrase; something new dated 5/6/10
<br />
<br /><a target=_blank class=ftalternatingbarlinklarge href="http://www.axcan.com/patient_product_update.php?lang=1">Ultrase: product update; Axcan website</a>
<br />
<br />In short, it's application/whatever was reviewed and more needs to be done before it can gain FDA approval- although at least it doesn't need to go through more clinical trials.
<br />
<br />
<br />The other enzyme people talked about on an old g-tube thread was, if I am remembering right, Pancrecarb... one of them (the 4's I think) came in tiny beads that could go through the tube easily. THAT one hasn't been FDA approved yet either... I hope that one becomes available a lot sooner than the Viokase. In the meantime, I am wondering how Emily's Creon is likely to work w/ the tube... and if we'll have to wake up during the night, etc etc.
<br />
<br />It's frustrating that now finding solutions until FDA approval for these meds means making changes for many months, not some brief little time period like originally hoped for. <img src="i/expressions/face-icon-small-frown.gif" border="0">
<br />
<br />This has been in the works since 2004... why did it have to come down to the wire like this and leave so many people in the lurch? It's not like they had to completely reinvent the things over the last 6 years or something... Sigh...

 

[crickit715]

harriet,
thats right! the mt or mk 4's.....didnt realize they were pancreacarb. great!! <img src="i/expressions/face-icon-small-sad.gif" border="0"> ....wow!! and the viokase capsules arent available either?? .....how in the world did no one forsee this all happening at once? arrrgghh!

 

[crickit715]

harriet,
thats right! the mt or mk 4's.....didnt realize they were pancreacarb. great!! <img src="i/expressions/face-icon-small-sad.gif" border="0"> ....wow!! and the viokase capsules arent available either?? .....how in the world did no one forsee this all happening at once? arrrgghh!

 

[crickit715]

harriet,
<br /> thats right! the mt or mk 4's.....didnt realize they were pancreacarb. great!! <img src="i/expressions/face-icon-small-sad.gif" border="0"> ....wow!! and the viokase capsules arent available either?? .....how in the world did no one forsee this all happening at once? arrrgghh!

 

[Robinadh]

We were giving our son the viokase caps. Opened them & mixed the powder with apple sauce. When it was unavailble we were give Cotazyme caps. Not the ECS but just the powder in a cap form. I'm in Canada so I'm not sure if its available in the US

 

[Robinadh]

We were giving our son the viokase caps. Opened them & mixed the powder with apple sauce. When it was unavailble we were give Cotazyme caps. Not the ECS but just the powder in a cap form. I'm in Canada so I'm not sure if its available in the US

 

[Robinadh]

We were giving our son the viokase caps. Opened them & mixed the powder with apple sauce. When it was unavailble we were give Cotazyme caps. Not the ECS but just the powder in a cap form. I'm in Canada so I'm not sure if its available in the US

 

[mike2616]

Viokase has been pulled by the FDA.  It has been over 2 years and they still have not allowed it back on the market even though on their own site they say it is not a safety issue but a manufacturing one.  Personally, I have been on it since 1987, and I don't care if they were mixing it in a wino's shoe...it worked and the "substitutes" don't.  I called the company that makes it and all they say is they are working with the FDA.  The only constructive advice she gave was that everyone who needs the drug should call the FDA and let them know that people are waiting.  So, if you want to do that the number is 1-888-463-6332.      If people make enough noise maybe something will be done.<br>

 

[mike2616]

Viokase has been pulled by the FDA. It has been over 2 years and they still have not allowed it back on the market even though on their own site they say it is not a safety issue but a manufacturing one. Personally, I have been on it since 1987, and I don't care if they were mixing it in a wino's shoe...it worked and the "substitutes" don't. I called the company that makes it and all they say is they are working with the FDA. The only constructive advice she gave was that everyone who needs the drug should call the FDA and let them know that people are waiting. So, if you want to do that the number is 1-888-463-6332. If people make enough noise maybe something will be done.<br>

 

[mike2616]

Viokase has been pulled by the FDA. It has been over 2 years and they still have not allowed it back on the market even though on their own site they say it is not a safety issue but a manufacturing one. Personally, I have been on it since 1987, and I don't care if they were mixing it in a wino's shoe...it worked and the "substitutes" don't. I called the company that makes it and all they say is they are working with the FDA. The only constructive advice she gave was that everyone who needs the drug should call the FDA and let them know that people are waiting. So, if you want to do that the number is 1-888-463-6332. If people make enough noise maybe something will be done.<br>

 

[hmw]

This thread was started back when the FDA deadline passed and several enzymes ultimately became unavailable (Ultrase, Pancrecarb and Viokase) due to never gaining their approval.

When you say that you contacted Axcan and they are 'still working' on it- how long ago was this? Axcan has acquired (not sure of the dynamic) the company that manufactures Zenpep so it makes me wonder how much interest they would now have in either of their old products.