Zenpep

hmw · Dec 20, 2009

<div class="FTQUOTE"><begin quote>Are all the Other Brands of Pancreatic Enzyme's
NOT Approved by the FDA ??</end quote></div>
All of them will be required to attain FDA approval status or they won't be able to continue to be sold. I am not sure what the deadline for this is.

Creon has attained FDA approval status and was the first brand to do so (you have probably seen threads referring to the new Creon formulation on the boards already. Creon used to be sold as 5's, 10's and 20's... now it's 6, 12 and 24. The active ingredient has NOT been changed but labeling needed to change due to the process it underwent to attain approval.) I am not sure if any other brand has yet achieved this status but they are all in this process.

hmw · Dec 20, 2009

<div class="FTQUOTE"><begin quote>Are all the Other Brands of Pancreatic Enzyme's
NOT Approved by the FDA ??</end quote></div>
All of them will be required to attain FDA approval status or they won't be able to continue to be sold. I am not sure what the deadline for this is.

Creon has attained FDA approval status and was the first brand to do so (you have probably seen threads referring to the new Creon formulation on the boards already. Creon used to be sold as 5's, 10's and 20's... now it's 6, 12 and 24. The active ingredient has NOT been changed but labeling needed to change due to the process it underwent to attain approval.) I am not sure if any other brand has yet achieved this status but they are all in this process.

hmw · Dec 20, 2009

<div class="FTQUOTE"><begin quote>Are all the Other Brands of Pancreatic Enzyme's
NOT Approved by the FDA ??</end quote></div>
All of them will be required to attain FDA approval status or they won't be able to continue to be sold. I am not sure what the deadline for this is.

Creon has attained FDA approval status and was the first brand to do so (you have probably seen threads referring to the new Creon formulation on the boards already. Creon used to be sold as 5's, 10's and 20's... now it's 6, 12 and 24. The active ingredient has NOT been changed but labeling needed to change due to the process it underwent to attain approval.) I am not sure if any other brand has yet achieved this status but they are all in this process.

hmw · Dec 20, 2009

<div class="FTQUOTE"><begin quote>Are all the Other Brands of Pancreatic Enzyme's
NOT Approved by the FDA ??</end quote>
All of them will be required to attain FDA approval status or they won't be able to continue to be sold. I am not sure what the deadline for this is.

Creon has attained FDA approval status and was the first brand to do so (you have probably seen threads referring to the new Creon formulation on the boards already. Creon used to be sold as 5's, 10's and 20's... now it's 6, 12 and 24. The active ingredient has NOT been changed but labeling needed to change due to the process it underwent to attain approval.) I am not sure if any other brand has yet achieved this status but they are all in this process.

hmw · Dec 20, 2009

<div class="FTQUOTE"><begin quote>Are all the Other Brands of Pancreatic Enzyme's
<br />NOT Approved by the FDA ??</end quote>
<br />All of them will be required to attain FDA approval status or they won't be able to continue to be sold. I am not sure what the deadline for this is.
<br />
<br />Creon has attained FDA approval status and was the first brand to do so (you have probably seen threads referring to the new Creon formulation on the boards already. Creon used to be sold as 5's, 10's and 20's... now it's 6, 12 and 24. The active ingredient has NOT been changed but labeling needed to change due to the process it underwent to attain approval.) I am not sure if any other brand has yet achieved this status but they are all in this process.

NYCLawGirl · Dec 20, 2009

The lack of FDA approval for other brands has to do with a labeling issue, not a safety or efficacy issue. Basically the enzymes are a little "overstuffed", so the FDA is requiring them to relabel (ex: Creon 20 went to 24, as Harriett noted above). Other enzyme brands will likely be going through similar steps to get their enzymes approved, but no one expects the formulas to change much (if any).

NYCLawGirl · Dec 20, 2009

The lack of FDA approval for other brands has to do with a labeling issue, not a safety or efficacy issue. Basically the enzymes are a little "overstuffed", so the FDA is requiring them to relabel (ex: Creon 20 went to 24, as Harriett noted above). Other enzyme brands will likely be going through similar steps to get their enzymes approved, but no one expects the formulas to change much (if any).

NYCLawGirl · Dec 20, 2009

The lack of FDA approval for other brands has to do with a labeling issue, not a safety or efficacy issue. Basically the enzymes are a little "overstuffed", so the FDA is requiring them to relabel (ex: Creon 20 went to 24, as Harriett noted above). Other enzyme brands will likely be going through similar steps to get their enzymes approved, but no one expects the formulas to change much (if any).

NYCLawGirl · Dec 20, 2009

The lack of FDA approval for other brands has to do with a labeling issue, not a safety or efficacy issue. Basically the enzymes are a little "overstuffed", so the FDA is requiring them to relabel (ex: Creon 20 went to 24, as Harriett noted above). Other enzyme brands will likely be going through similar steps to get their enzymes approved, but no one expects the formulas to change much (if any).

NYCLawGirl · Dec 20, 2009

The lack of FDA approval for other brands has to do with a labeling issue, not a safety or efficacy issue. Basically the enzymes are a little "overstuffed", so the FDA is requiring them to relabel (ex: Creon 20 went to 24, as Harriett noted above). Other enzyme brands will likely be going through similar steps to get their enzymes approved, but no one expects the formulas to change much (if any).

Lex · Dec 20, 2009