What's new
By:
Filters
Cystic Fibrosis Forum (EXP)

This is a sample guest message. Register a free account today to become a member! Once signed in, you'll be able to participate on this site by adding your own topics and posts, as well as connect with other members through your own private inbox!

FDA Approval of Enzymes??

H

hmw

New member
Sakem, what is your/your doctor's source for that? There is information on the Axcan website dated April 12, 2010 indicating otherwise (that we can expect approval, although it might take a little while.)

quote from Axcan's site (link in my prior post)
<div class="FTQUOTE"><begin quote><b>Will ULTRASE® MT or VIOKASE® be approved?</b>
Axcan remains highly committed to obtaining approval of its pending NDAs for ULTRASE® MT and VIOKASE®, although we do not know whether the NDAs will be approved prior to April 28th, 2010.

<b>When will ULTRASE® MT or VIOKASE® be approved?</b>
While we cannot predict timing of the approvals, Axcan remains highly committed to obtaining approval of its pending NDAs for ULTRASE® MT and VIOKASE®, although we do not know whether the NDAs will be approved prior to April 28th, 2010.</end quote></div>

Zenpep is manufactured by Eurand Pharmaceuticals.

Ultrase and Viokase are manufactured by Axcan Pharma Inc.
 
H

hmw

New member
Sakem, what is your/your doctor's source for that? There is information on the Axcan website dated April 12, 2010 indicating otherwise (that we can expect approval, although it might take a little while.)

quote from Axcan's site (link in my prior post)
<div class="FTQUOTE"><begin quote><b>Will ULTRASE® MT or VIOKASE® be approved?</b>
Axcan remains highly committed to obtaining approval of its pending NDAs for ULTRASE® MT and VIOKASE®, although we do not know whether the NDAs will be approved prior to April 28th, 2010.

<b>When will ULTRASE® MT or VIOKASE® be approved?</b>
While we cannot predict timing of the approvals, Axcan remains highly committed to obtaining approval of its pending NDAs for ULTRASE® MT and VIOKASE®, although we do not know whether the NDAs will be approved prior to April 28th, 2010.</end quote></div>

Zenpep is manufactured by Eurand Pharmaceuticals.

Ultrase and Viokase are manufactured by Axcan Pharma Inc.
 
H

hmw

New member
Sakem, what is your/your doctor's source for that? There is information on the Axcan website dated April 12, 2010 indicating otherwise (that we can expect approval, although it might take a little while.)

quote from Axcan's site (link in my prior post)
<div class="FTQUOTE"><begin quote><b>Will ULTRASE® MT or VIOKASE® be approved?</b>
Axcan remains highly committed to obtaining approval of its pending NDAs for ULTRASE® MT and VIOKASE®, although we do not know whether the NDAs will be approved prior to April 28th, 2010.

<b>When will ULTRASE® MT or VIOKASE® be approved?</b>
While we cannot predict timing of the approvals, Axcan remains highly committed to obtaining approval of its pending NDAs for ULTRASE® MT and VIOKASE®, although we do not know whether the NDAs will be approved prior to April 28th, 2010.</end quote></div>

Zenpep is manufactured by Eurand Pharmaceuticals.

Ultrase and Viokase are manufactured by Axcan Pharma Inc.
 
H

hmw

New member
Sakem, what is your/your doctor's source for that? There is information on the Axcan website dated April 12, 2010 indicating otherwise (that we can expect approval, although it might take a little while.)

quote from Axcan's site (link in my prior post)
<div class="FTQUOTE"><begin quote><b>Will ULTRASE® MT or VIOKASE® be approved?</b>
Axcan remains highly committed to obtaining approval of its pending NDAs for ULTRASE® MT and VIOKASE®, although we do not know whether the NDAs will be approved prior to April 28th, 2010.

<b>When will ULTRASE® MT or VIOKASE® be approved?</b>
While we cannot predict timing of the approvals, Axcan remains highly committed to obtaining approval of its pending NDAs for ULTRASE® MT and VIOKASE®, although we do not know whether the NDAs will be approved prior to April 28th, 2010.</end quote>

Zenpep is manufactured by Eurand Pharmaceuticals.

Ultrase and Viokase are manufactured by Axcan Pharma Inc.
 
H

hmw

New member
Sakem, what is your/your doctor's source for that? There is information on the Axcan website dated April 12, 2010 indicating otherwise (that we can expect approval, although it might take a little while.)
<br />
<br />quote from Axcan's site (link in my prior post)
<br /><div class="FTQUOTE"><begin quote><b>Will ULTRASE® MT or VIOKASE® be approved?</b>
<br />Axcan remains highly committed to obtaining approval of its pending NDAs for ULTRASE® MT and VIOKASE®, although we do not know whether the NDAs will be approved prior to April 28th, 2010.
<br />
<br /><b>When will ULTRASE® MT or VIOKASE® be approved?</b>
<br />While we cannot predict timing of the approvals, Axcan remains highly committed to obtaining approval of its pending NDAs for ULTRASE® MT and VIOKASE®, although we do not know whether the NDAs will be approved prior to April 28th, 2010.</end quote>
<br />
<br />Zenpep is manufactured by Eurand Pharmaceuticals.
<br />
<br />Ultrase and Viokase are manufactured by Axcan Pharma Inc.
 
M

mamaScarlett

Active member
So am I right in thinking Pancrease has been approved as of now...but it has been renamed...
oky doke. whatever.
anyone know if the drug itself has remained the same or what.
this is crazy. i heard whispers of this but didn't know exactly wht was going on.
 
M

mamaScarlett

Active member
So am I right in thinking Pancrease has been approved as of now...but it has been renamed...
oky doke. whatever.
anyone know if the drug itself has remained the same or what.
this is crazy. i heard whispers of this but didn't know exactly wht was going on.
 
M

mamaScarlett

Active member
So am I right in thinking Pancrease has been approved as of now...but it has been renamed...
oky doke. whatever.
anyone know if the drug itself has remained the same or what.
this is crazy. i heard whispers of this but didn't know exactly wht was going on.
 
M

mamaScarlett

Active member
So am I right in thinking Pancrease has been approved as of now...but it has been renamed...
oky doke. whatever.
anyone know if the drug itself has remained the same or what.
this is crazy. i heard whispers of this but didn't know exactly wht was going on.
 
M

mamaScarlett

Active member
So am I right in thinking Pancrease has been approved as of now...but it has been renamed...
<br />oky doke. whatever.
<br />anyone know if the drug itself has remained the same or what.
<br />this is crazy. i heard whispers of this but didn't know exactly wht was going on.
 
H

hmw

New member
According to this link, yes, they are the same.
<div class="FTQUOTE"><begin quote>Ortho-McNeil / Johnson and Johnson will continue to have their Pancrease MT products available for a short period to help patients transition over to their FDA-approved Pancreaze product. Pancrease MT and Pancreaze are identical products; however, the product packaging for Pancreaze complies with FDA requirements for reporting of enzyme contents.</end quote></div>
<a target=_blank class=ftalternatingbarlinklarge href="http://healthcare.utah.edu/pharmacy/alerts/447.htm">Pancreatic Enzyme Products - New Products and Changes in Product Availability</a> That link contains a good chart showing equivalents of old products and their new counterparts (and what had and hadn't yet attained fda approval as of 4/15.)
 
H

hmw

New member
According to this link, yes, they are the same.
<div class="FTQUOTE"><begin quote>Ortho-McNeil / Johnson and Johnson will continue to have their Pancrease MT products available for a short period to help patients transition over to their FDA-approved Pancreaze product. Pancrease MT and Pancreaze are identical products; however, the product packaging for Pancreaze complies with FDA requirements for reporting of enzyme contents.</end quote></div>
<a target=_blank class=ftalternatingbarlinklarge href="http://healthcare.utah.edu/pharmacy/alerts/447.htm">Pancreatic Enzyme Products - New Products and Changes in Product Availability</a> That link contains a good chart showing equivalents of old products and their new counterparts (and what had and hadn't yet attained fda approval as of 4/15.)
 
H

hmw

New member
According to this link, yes, they are the same.
<div class="FTQUOTE"><begin quote>Ortho-McNeil / Johnson and Johnson will continue to have their Pancrease MT products available for a short period to help patients transition over to their FDA-approved Pancreaze product. Pancrease MT and Pancreaze are identical products; however, the product packaging for Pancreaze complies with FDA requirements for reporting of enzyme contents.</end quote></div>
<a target=_blank class=ftalternatingbarlinklarge href="http://healthcare.utah.edu/pharmacy/alerts/447.htm">Pancreatic Enzyme Products - New Products and Changes in Product Availability</a> That link contains a good chart showing equivalents of old products and their new counterparts (and what had and hadn't yet attained fda approval as of 4/15.)
 
H

hmw

New member
According to this link, yes, they are the same.
<div class="FTQUOTE"><begin quote>Ortho-McNeil / Johnson and Johnson will continue to have their Pancrease MT products available for a short period to help patients transition over to their FDA-approved Pancreaze product. Pancrease MT and Pancreaze are identical products; however, the product packaging for Pancreaze complies with FDA requirements for reporting of enzyme contents.</end quote>
<a target=_blank class=ftalternatingbarlinklarge href="http://healthcare.utah.edu/pharmacy/alerts/447.htm">Pancreatic Enzyme Products - New Products and Changes in Product Availability</a> That link contains a good chart showing equivalents of old products and their new counterparts (and what had and hadn't yet attained fda approval as of 4/15.)
 
H

hmw

New member
According to this link, yes, they are the same.
<br /><div class="FTQUOTE"><begin quote>Ortho-McNeil / Johnson and Johnson will continue to have their Pancrease MT products available for a short period to help patients transition over to their FDA-approved Pancreaze product. Pancrease MT and Pancreaze are identical products; however, the product packaging for Pancreaze complies with FDA requirements for reporting of enzyme contents.</end quote>
<br /><a target=_blank class=ftalternatingbarlinklarge href="http://healthcare.utah.edu/pharmacy/alerts/447.htm">Pancreatic Enzyme Products - New Products and Changes in Product Availability</a> That link contains a good chart showing equivalents of old products and their new counterparts (and what had and hadn't yet attained fda approval as of 4/15.)
 
You must log in or register to reply here.
Top