Creon

Treats exocrine pancreatic insufficiency. BLA 20725, held by Abbvie. Pancrelipase (Amylase;Lipase;Protease).

As of Nov 13, 2026, BLA 20725 (Creon), held by Abbvie, was first approved by FDA on Apr 30, 2009, with 19 approved supplements and 0 published complete response letters.

First approved: Apr 30, 2009
Review: Priority
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CREON is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jul 12, 2011	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label
Jul 29, 2010	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 30, 2010	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 30, 2009	Original applicationTYPE 7 · Priority review	Approved	Review Label Summary Review Letter

Products

5 strengths and forms

Product	Active ingredient	Marketing
Creon30,000USP UNITS;6,000USP UNITS;19,000USP UNITS · capsule, delayed release;oral	Pancrelipase (Amylase;Lipase;Protease)	Rx
Creon60,000USP UNITS;12,000USP UNITS;38,000USP UNITS · capsule, delayed release;oral	Pancrelipase (Amylase;Lipase;Protease)	Rx
Creon120,000USP UNITS;24,000USP UNITS;76,000USP UNITS · capsule, delayed release;oral	Pancrelipase (Amylase;Lipase;Protease)	Rx
Creon15,000USP UNITS;3,000USP UNITS;9,500USP UNITS · capsule, delayed release;oral	Pancrelipase (Amylase;Lipase;Protease)	Rx
Creon180,000USP UNITS;36,000USP UNITS;114,000USP UNITS · capsule, delayed release;oral	Pancrelipase (Amylase;Lipase;Protease)	Rx

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 28, 2024	Supplement 31Labeling · Standard review	Approved	Letter Label Medication Guide
Jun 2, 2022	Supplement 28Labeling · Standard review	Approved	Label Letter
Mar 20, 2020	Supplement 26Labeling · Standard review	Approved	Label Letter
May 9, 2019	Supplement 25Labeling · Standard review	Approved	Letter
Jun 16, 2016	Supplement 23Manufacturing · Priority review	Approved	None posted
Apr 10, 2015	Supplement 22Manufacturing · Priority review	Approved	None posted
Jan 5, 2015	Supplement 21Manufacturing · Priority review	Approved	None posted
Nov 21, 2014	Supplement 18Manufacturing · Priority review	Approved	None posted
Nov 19, 2014	Supplement 20Manufacturing · Priority review	Approved	None posted
Mar 17, 2014	Supplement 9Manufacturing · Priority review	Approved	None posted
Mar 14, 2013	Supplement 16Manufacturing · Priority review	Approved	Label
Feb 28, 2013	Supplement 17Manufacturing · Priority review	Approved	None posted
Nov 20, 2012	Supplement 15Manufacturing · Priority review	Approved	None posted
Jul 12, 2011	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label
Jun 10, 2011	Supplement 11Manufacturing · Priority review	Approved	Label Letter Pediatric Clinical Pharmacology Review Pediatric Medical Review
May 9, 2011	Supplement 14REMS	Approved	Letter Label
Aug 12, 2010	Supplement 7REMS	Approved	Label Letter
Jul 29, 2010	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 30, 2010	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 30, 2009	Original applicationTYPE 7 · Priority review	Approved	Review Label Summary Review Letter

Identifiers

Application: BLA 20725
Drugs@FDA: Overview at FDA
Company: AbbVie

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters