Alerts
Creon – Newly Approved Formulation Requires New Prescription
July 6, 2009
Creon Delayed-Release Capsules were approved on April 30, 2009 and will be available in July, 2009. Previously marketed as Creon Minimicrospheres, Creon Delayed-Release Capsules are the first FDA-approved pancreatic enzyme product. The new formulation will be available in 3 strengths summarized in the Table.
Table. Available Presentations of Creon Delayed-Release Capsules
| Product | Product Size | Lipase (USP units) | Protease (USP units) | Amylase (USP units) | NDC number | Equivalent Old Product |
| Creon Delayed Release Capsules | 100 capsules | 6,000 | 19,000 | 30,000 | 00032-1206-01 | Creon 5 |
| 250 capsules | 6,000 | 19,000 | 30,000 | 00032-1206-07 | Creon 5 | |
| Creon Delayed Release Capsules | 100 capsules | 12,000 | 38,000 | 60,000 | 00032-1212-01 | Creon 10 |
| 250 capsules | 12,000 | 38,000 | 60,000 | 00032-1212-07 | Creon 10 | |
| Creon Delayed Release Capsules | 100 capsules | 24,000 | 76,000 | 120,000 | 00032-1224-01 | Creon 20 |
| 250 capsules | 24,000 | 76,000 | 120,000 | 00032-1224-07 | Creon 20 |
Patients currently receiving therapy with Creon Minimicrospheres will need a new prescription for Creon Delayed-Release Capsules. The manufacturer recommends switching patients to the new formulation on a capsule per capsule basis. For example, 4 capsules of Creon 5 Minimicrospheres is equivalent to 4 capsules of Creon Delayed Release Capsules lipase 6,000 USP units, protease 19,000 USP units, amylase 30,000 USP units.
Additional details are available at the following links:
- Solvay Pharmaceuticals – Dear Healthcare Provider:
scan07-02-2009.pdf - Product Labeling – Creon Delayed-Release Capsules:
020725s000lbl.pdf
Updated
July 6, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
