Alerts
Pancreatic Enzyme Products - New Products and Changes in Product Availability - UPDATED
June 16, 2010
Two pancreatic enzyme products were FDA-approved in 2009 - Creon and Zenpep. A third pancreatic enzyme product, Pancreaze, received FDA approval on April 12, 2010. These three products are the only FDA-approved products, although they are not AB-rated to each other. X-Gen, distributes the 5,000 unit strength of Zenpep as an authorized generic product. This product cannot be AB-rated to Zenpep because it is the identical product. However, it may be used interchangeably with the Zenpep 5,000 unit product. All other marketed pancreatic enzyme products are unapproved drugs, which are not AB-rated and may not be interchanged.
In 2004, FDA issued a mandate requiring manufacturers of pancreatic enzyme products to seek approval through the New Drug Application (NDA) process, in response to concerns about potential for patient harm and lack of ingredient standardization. At that time, all marketed pancreatic enzyme products were unapproved drugs. The manufacturers were given until April 28, 2010 to obtain NDA approval, in order to continue marketing their products. With the exception of Pancrease MT (see next paragraph), unapproved pancreatic enzyme replacement products may no longer be marketed.
Several manufacturers have discontinued their unapproved pancreatic enzyme products, including Ethex, Major, Solvay, and X-Gen. Solvay discontinued their Creon Minimicrospheres products and will continue marketing their FDA-approved Creon product. In November 2009, X-Gen stopped distributing their unapproved pancreatic enzyme products, although they will continue distributing the authorized generic for the Zenpep 5,000 unit product. Ortho-McNeil / Johnson and Johnson is allowed to continue distributing their Pancrease MT products until July 12, 2010 to help patients transition over to their FDA-approved Pancreaze product. Pharmacies may dispense Pancrease MT to patients through July 31, 2010. Pancrease MT and Pancreaze are identical products; however, the product packaging for Pancreaze complies with FDA requirements for reporting of enzyme contents.
Patients currently receiving therapy with pancreatic enzyme products will need a new prescription if they need to switch to another product. There are no recommendations for switching patients between products from different manufacturers. Clinicians may consider switching the patient to another product with a similar amount of enzymes, then adjusting the dose based on patient response. However, the labeled enzyme contents may differ between FDA-approved products and unapproved products, which may make it more difficult to switch between products. The labeled contents of FDA-approved products reflect the actual enzyme content of the product, while the labeled contents of unapproved products excludes overfill and underestimates the actual lipase content. The table shows the recently available agents, along with any available equivalents.
Table. Presentations of Pancrelipase Products
| Product | Lipase (USP units) | Protease (USP units) | Amylase (USP units) | NDC numbers | Equivalent |
| FDA- Approved Products - Labeled Content Reflects Actual Amount | |||||
| Creon Delayed Release Capsules (Solvay) | 6,000 | 19,000 | 30,000 | 100s: 00032-1206-01 250s: 00032-1206-07 |
Creon 5 (old formulation) |
| Creon Delayed Release Capsules (Solvay) | 12,000 | 38,000 | 60,000 | 100s: 00032-1212-01 250s: 00032-1212-07 |
Creon 10 (old formulation) |
| Creon Delayed Release Capsules (Solvay) | 24,000 | 76,000 | 120,000 | 100s: 00032-1224-01 250s: 00032-1224-07 |
Creon 20 (old formulation) |
| Pancreaze Delayed-Release Capsules (Ortho-McNeil / Johnson and Johnson) | 4,200 | 10,000 | 17,500 | 100s: 50458-0341-60 | Pancrease MT 4 |
| Pancreaze Delayed-Release Capsules (Ortho-McNeil / Johnson and Johnson) | 10,500 | 25,000 | 43,750 | 100s: 50458-0342-60 | Pancrease MT 10 |
| Pancreaze Delayed-Release Capsules (Ortho-McNeil / Johnson and Johnson) | 16,800 | 40,000 | 70,000 | 100s: 50458-0343-60 | Pancrease MT 16 |
| Pancreaze Delayed-Release Capsules (Ortho-McNeil / Johnson and Johnson) | 21,000 | 37,000 | 61,000 | 100s: 50458-0346-60 | Pancrease MT 20 |
| Zenpep Delayed-Release Capsules (Eurand) | 5,000 | 17,000 | 27,000 | 12s: 42865-100-01 100s: 42865-100-02 |
X-gen pancrelipase 5,000 units (new formulation) |
| Zenpep Delayed-Release Capsules (Eurand) | 10,000 | 34,000 | 55,000 | 12s: 42865-101-01 100s: 42865-101-02 |
None |
| Zenpep Delayed-Release Capsules (Eurand) | 15,000 | 51,000 | 82,000 | 12s: 42865-102-01 100s: 42865-102-02 |
None |
| Zenpep Delayed-Release Capsules (Eurand) | 20,000 | 68,000 | 109,000 | 12s: 42865-103-01 100s: 42865-103-04 |
None |
| Pancrelipase Delayed-Release Capsules (X-Gen)* | 5,000 | 17,000 | 27,000 | 100s: 39822-0205-1 | Zenpep 5,000 units |
| Unapproved Products Which May Be Distributed Until July 12, 2010 - Labeled Content May Underestimate Actual Amount | |||||
| Pancrease MT 4 Capsules (Ortho-McNeil / Johnson and Johnson) | 4,000 | 12,000 | 12,000 | 100s: 00045-0341-60 | Pancreaze 4,200 |
| Pancrease MT 10 Capsules (Ortho-McNeil / Johnson and Johnson) | 10,000 | 30,000 | 30,000 | 100s: 00045-0342-60 | Pancreaze 10,500 |
| Pancrease MT 16 Capsules (Ortho-McNeil / Johnson and Johnson) | 16,000 | 48,000 | 48,000 | 100s: 00045-0343-60 | Pancreaze 16,800 |
| Pancrease MT 20 Capsules (Ortho-McNeil / Johnson and Johnson) | 20,000 | 44,000 | 56,000 | 100s: 00045-0346-60 | Pancreaze 21,000 |
| Unapproved Products Which May No Longer Be Distributed - Labeled Content May Underestimate Actual Lipase Amount | |||||
| Pancrecarb MS-4 Delayed-Release Capsules (Digestive Care) | 4,000 | 25,000 | 25,000 | 100s: 59767-0002-01 | None |
| Pancrecarb MS-8 Delayed-Release Capsules (Digestive Care) | 8,000 | 45,000 | 40,000 | 100s: 59767-0001-01 250s: 59767-0001-02 |
None |
| Pancrecarb MS-16 Delayed-Release Capsules (Digestive Care) | 16,000 | 52,000 | 52,000 | 100s: 59767-0003-01 250s: 59767-0003-02 |
None |
| Ultrase Capsules (Axcan Scandipharm) | 4,500 | 25,000 | 20,000 | 100s: 58914-0045-10 | None |
| Ultrase MT12 Capsules (Axcan Scandipharm) | 12,000 | 39,000 | 39,000 | 100s: 58914-0002-10 | None |
| Ultrase MT18 Capsules (Axcan Scandipharm) | 18,000 | 58,500 | 58,500 | 100s: 58914-0018-10 | None |
| Ultrase MT20 Capsules (Axcan Scandipharm) | 20,000 | 65,000 | 65,000 | 100s: 58914-0004-10 500s: 58914-0004-50 |
None |
| Viokase 8 Tablets (Axcan Scandipharm) | 8,000 | 30,000 | 30,000 | 100s: 58914-0111-10 | None |
| Viokase 16 Tablets (Axcan Scandipharm) | 16,000 | 60,000 | 60,000 | 100s: 58914-0116-10 | None |
Additional details are available at the following links:
- Questions and Answers for Healthcare Professionals and the Public: Use an Approved Pancreatic Enzyme Product (PEP):
http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm204745.htm - FDA Guidance for Industry on Pancreatic Enzymes:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071651.pdf - Food and Drug Administration. exocrine pancreatic insufficiency drug products; extension to obtain marketing approval. Federal Register 2007;72(207):60860-60862.
http://edocket.access.gpo.gov/2007/E7-21082.htm - Pancreatic Enzyme Information:
http://www.pancreaticenzymeinfo.com/ - Solvay Pharmaceuticals – Dear Healthcare Provider:
http://healthcare.utah.edu/pharmacy/alerts/scan07-02-2009.pdf - Creon Frequently-Asked Questions:
http://www.creon-us.com/Faq.htm - Creon Delayed-Release Capsules Product Labeling:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020725s000lbl.pdf - Pancreaze Delayed-Release Capsules Product Labeling:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022523lbl.pdf - X-Gen Pancrelipase Product Information Page:
http://www.x-gen.us.com/Specialty%20Division/page6.html - X-Gen Pancrelipase Product Labeling:
http://www.x-gen.us.com/Specialty%20Division/18/Pancrelipase_files/insert/Pancrelipase_pi.pdf - Zenpep Product Labeling:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022210s000lbl.pdf - Related Alert – Creon – Newly Approved Formulation Requires New Prescription:
http://healthcare.utah.edu/pharmacy/alerts/391.htm
June 16, 2010; April 30, 2010; April 15, 2010; March 4, 2010; January 22, 2010. University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT
