FDA Approval of Enzymes??

[dragonlady]

Excuse me for a second....what the ????

This is the first time I have heard of it also and my daughter is on medicad. We use Ultrase.

This has been the worst year for trying to get medication. I have never had this much trouble before. I have to say this is a little concerning to hear of something else being a problem to get.

 

[dragonlady]

Excuse me for a second....what the ????

This is the first time I have heard of it also and my daughter is on medicad. We use Ultrase.

This has been the worst year for trying to get medication. I have never had this much trouble before. I have to say this is a little concerning to hear of something else being a problem to get.

 

[dragonlady]

Excuse me for a second....what the ????

This is the first time I have heard of it also and my daughter is on medicad. We use Ultrase.

This has been the worst year for trying to get medication. I have never had this much trouble before. I have to say this is a little concerning to hear of something else being a problem to get.

 

[dragonlady]

Excuse me for a second....what the ????

This is the first time I have heard of it also and my daughter is on medicad. We use Ultrase.

This has been the worst year for trying to get medication. I have never had this much trouble before. I have to say this is a little concerning to hear of something else being a problem to get.

 

[dragonlady]

Excuse me for a second....what the ????
<br />
<br />This is the first time I have heard of it also and my daughter is on medicad. We use Ultrase.
<br />
<br />This has been the worst year for trying to get medication. I have never had this much trouble before. I have to say this is a little concerning to hear of something else being a problem to get.

 

[petnurse]

I don't know. My letter came directly from my insurance company. We get our prescriptions filled at walgreen's and we are under the free program for Ultrase until my son turns four. I'm not sure if we will still be able to get it. I was going to wait to hear from my CF dr as we have plenty. You can always call your CF center and see what they know. They may have to write you a new prescription :-(

 

[petnurse]

I don't know. My letter came directly from my insurance company. We get our prescriptions filled at walgreen's and we are under the free program for Ultrase until my son turns four. I'm not sure if we will still be able to get it. I was going to wait to hear from my CF dr as we have plenty. You can always call your CF center and see what they know. They may have to write you a new prescription :-(

 

[petnurse]

I don't know. My letter came directly from my insurance company. We get our prescriptions filled at walgreen's and we are under the free program for Ultrase until my son turns four. I'm not sure if we will still be able to get it. I was going to wait to hear from my CF dr as we have plenty. You can always call your CF center and see what they know. They may have to write you a new prescription :-(

 

[petnurse]

I don't know. My letter came directly from my insurance company. We get our prescriptions filled at walgreen's and we are under the free program for Ultrase until my son turns four. I'm not sure if we will still be able to get it. I was going to wait to hear from my CF dr as we have plenty. You can always call your CF center and see what they know. They may have to write you a new prescription :-(

 

[petnurse]

I don't know. My letter came directly from my insurance company. We get our prescriptions filled at walgreen's and we are under the free program for Ultrase until my son turns four. I'm not sure if we will still be able to get it. I was going to wait to hear from my CF dr as we have plenty. You can always call your CF center and see what they know. They may have to write you a new prescription :-(

 

[ej0820]

a new prescription is what I'm worried about. How many belly aches or side effects will I have to go through before we find the right one?? Ultrase has never, ever done me wrong. <img src="i/expressions/face-icon-small-sad.gif" border="0">

 

[ej0820]

a new prescription is what I'm worried about. How many belly aches or side effects will I have to go through before we find the right one?? Ultrase has never, ever done me wrong. <img src="i/expressions/face-icon-small-sad.gif" border="0">

 

[ej0820]

a new prescription is what I'm worried about. How many belly aches or side effects will I have to go through before we find the right one?? Ultrase has never, ever done me wrong. <img src="i/expressions/face-icon-small-sad.gif" border="0">

 

[ej0820]

a new prescription is what I'm worried about. How many belly aches or side effects will I have to go through before we find the right one?? Ultrase has never, ever done me wrong. <img src="i/expressions/face-icon-small-sad.gif" border="0">

 

[ej0820]

a new prescription is what I'm worried about. How many belly aches or side effects will I have to go through before we find the right one?? Ultrase has never, ever done me wrong. <img src="i/expressions/face-icon-small-sad.gif" border="0">

 

[hmw]

I can't believe this is the first all of you are hearing about this! <img src="i/expressions/face-icon-small-mad.gif" border="0"> Shame on your clinics for not making all of you aware of this sooner- this has been in the works for years now (trials w/ the enzymes as they work through the fda approval process- they've been sold to date as a 'grandfathered' drug, since they have been available since before the current regulating process) and the final deadline for drugs to gain approval is the end of this month.

Maybe they all assumed that all of the brands would gain their approvals in time and it never would be an issue, but a heads-up would certainly have been nice (and maybe writing a really big rx to fill over the last few months to tide you over in case gaining approval takes longer.) Creon was the first to gain approval, followed by the brand-new Zenpep. Pancreaze (Johnson & Johnson/Ortho) is the most recent (formerly known as Pancrease MT's) to gain approval.

Ultrase and Viokase is in the works, according to this press release by Axcan... but it may not be in time for the 4/28 deadline.
<a target=_blank class=ftalternatingbarlinklarge href="http://www.axcan.com/patient_product_qa.php?lang=1">Axcan.com Q&A re. enzymes</a>

eta> I'm looking for something from Pancrecarb to see if they are close to gaining approval but so far I can't find anything. As of this past Sept. they were 'close' but I'd like to find something more recent.

 

[hmw]

I can't believe this is the first all of you are hearing about this! <img src="i/expressions/face-icon-small-mad.gif" border="0"> Shame on your clinics for not making all of you aware of this sooner- this has been in the works for years now (trials w/ the enzymes as they work through the fda approval process- they've been sold to date as a 'grandfathered' drug, since they have been available since before the current regulating process) and the final deadline for drugs to gain approval is the end of this month.

Maybe they all assumed that all of the brands would gain their approvals in time and it never would be an issue, but a heads-up would certainly have been nice (and maybe writing a really big rx to fill over the last few months to tide you over in case gaining approval takes longer.) Creon was the first to gain approval, followed by the brand-new Zenpep. Pancreaze (Johnson & Johnson/Ortho) is the most recent (formerly known as Pancrease MT's) to gain approval.

Ultrase and Viokase is in the works, according to this press release by Axcan... but it may not be in time for the 4/28 deadline.
<a target=_blank class=ftalternatingbarlinklarge href="http://www.axcan.com/patient_product_qa.php?lang=1">Axcan.com Q&A re. enzymes</a>

eta> I'm looking for something from Pancrecarb to see if they are close to gaining approval but so far I can't find anything. As of this past Sept. they were 'close' but I'd like to find something more recent.

 

[hmw]

I can't believe this is the first all of you are hearing about this! <img src="i/expressions/face-icon-small-mad.gif" border="0"> Shame on your clinics for not making all of you aware of this sooner- this has been in the works for years now (trials w/ the enzymes as they work through the fda approval process- they've been sold to date as a 'grandfathered' drug, since they have been available since before the current regulating process) and the final deadline for drugs to gain approval is the end of this month.

Maybe they all assumed that all of the brands would gain their approvals in time and it never would be an issue, but a heads-up would certainly have been nice (and maybe writing a really big rx to fill over the last few months to tide you over in case gaining approval takes longer.) Creon was the first to gain approval, followed by the brand-new Zenpep. Pancreaze (Johnson & Johnson/Ortho) is the most recent (formerly known as Pancrease MT's) to gain approval.

Ultrase and Viokase is in the works, according to this press release by Axcan... but it may not be in time for the 4/28 deadline.
<a target=_blank class=ftalternatingbarlinklarge href="http://www.axcan.com/patient_product_qa.php?lang=1">Axcan.com Q&A re. enzymes</a>

eta> I'm looking for something from Pancrecarb to see if they are close to gaining approval but so far I can't find anything. As of this past Sept. they were 'close' but I'd like to find something more recent.

 

[hmw]

I can't believe this is the first all of you are hearing about this! <img src="i/expressions/face-icon-small-mad.gif" border="0"> Shame on your clinics for not making all of you aware of this sooner- this has been in the works for years now (trials w/ the enzymes as they work through the fda approval process- they've been sold to date as a 'grandfathered' drug, since they have been available since before the current regulating process) and the final deadline for drugs to gain approval is the end of this month.

Maybe they all assumed that all of the brands would gain their approvals in time and it never would be an issue, but a heads-up would certainly have been nice (and maybe writing a really big rx to fill over the last few months to tide you over in case gaining approval takes longer.) Creon was the first to gain approval, followed by the brand-new Zenpep. Pancreaze (Johnson & Johnson/Ortho) is the most recent (formerly known as Pancrease MT's) to gain approval.

Ultrase and Viokase is in the works, according to this press release by Axcan... but it may not be in time for the 4/28 deadline.
<a target=_blank class=ftalternatingbarlinklarge href="http://www.axcan.com/patient_product_qa.php?lang=1">Axcan.com Q&A re. enzymes</a>

eta> I'm looking for something from Pancrecarb to see if they are close to gaining approval but so far I can't find anything. As of this past Sept. they were 'close' but I'd like to find something more recent.

 

[hmw]

I can't believe this is the first all of you are hearing about this! <img src="i/expressions/face-icon-small-mad.gif" border="0"> Shame on your clinics for not making all of you aware of this sooner- this has been in the works for years now (trials w/ the enzymes as they work through the fda approval process- they've been sold to date as a 'grandfathered' drug, since they have been available since before the current regulating process) and the final deadline for drugs to gain approval is the end of this month.
<br />
<br />Maybe they all assumed that all of the brands would gain their approvals in time and it never would be an issue, but a heads-up would certainly have been nice (and maybe writing a really big rx to fill over the last few months to tide you over in case gaining approval takes longer.) Creon was the first to gain approval, followed by the brand-new Zenpep. Pancreaze (Johnson & Johnson/Ortho) is the most recent (formerly known as Pancrease MT's) to gain approval.
<br />
<br />Ultrase and Viokase is in the works, according to this press release by Axcan... but it may not be in time for the 4/28 deadline.
<br /><a target=_blank class=ftalternatingbarlinklarge href="http://www.axcan.com/patient_product_qa.php?lang=1">Axcan.com Q&A re. enzymes</a>
<br />
<br />eta> I'm looking for something from Pancrecarb to see if they are close to gaining approval but so far I can't find anything. As of this past Sept. they were 'close' but I'd like to find something more recent.