Treats exocrine pancreatic insufficiency. BLA 22523, held by Vivus Inc. Pancrelipase (Amylase;Lipase;Protease).
As of Nov 13, 2026, BLA 22523 (Pancreaze), held by Vivus Inc, was first approved by FDA on Apr 12, 2010, with 13 approved supplements and 0 published complete response letters.
PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 12, 2010 | Original applicationTYPE 7 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pancreaze24,600USP UNITS; 4,200USP UNITS; 14,200USP UNITS · capsule, delayed release;oral | Pancrelipase (Amylase;Lipase;Protease) | Rx |
| Pancreaze61,500USP UNITS; 10,500USP UNITS; 35,500USP UNITS · capsule, delayed release;oral | Pancrelipase (Amylase;Lipase;Protease) | Rx |
| Pancreaze98,400USP UNITS; 16,800USP UNITS; 56,800USP UNITS · capsule, delayed release;oral | Pancrelipase (Amylase;Lipase;Protease) | Rx |
| Pancreaze83,900USP UNITS; 21,000USP UNITS; 54,700USP UNITS · capsule, delayed release;oral | Pancrelipase (Amylase;Lipase;Protease) | Rx |
| Pancreaze149,900USP UNITS; 37,000USP UNITS; 97,300USP UNITS · capsule, delayed release;oral | Pancrelipase (Amylase;Lipase;Protease) | Rx |
| Pancreaze15,200USP UNITS; 2,600USP UNITS; 8,800USP UNITS · capsule, delayed release;oral | Pancrelipase (Amylase;Lipase;Protease) | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2024 | Supplement 19Labeling · Standard review | Approved | |
| Apr 26, 2021 | Supplement 16Labeling · Standard review | Approved | |
| Mar 20, 2020 | Supplement 13Labeling · Standard review | Approved | |
| Jan 28, 2020 | Supplement 14Manufacturing | Approved | |
| Aug 4, 2016 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 16, 2016 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Mar 30, 2015 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Mar 3, 2015 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jun 23, 2014 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| May 27, 2014 | Supplement 5Manufacturing · Standard review | Approved | |
| Mar 7, 2014 | Supplement 4Manufacturing · Standard review | Approved | |
| Dec 7, 2012 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jun 20, 2011 | Supplement 2REMS | Approved | |
| Apr 12, 2010 | Original applicationTYPE 7 · Standard review | Approved |
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
