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:
- Product Labeling – Creon Delayed-Release Capsules:
July 6, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.