Treats exocrine pancreatic insufficiency. BLA 22175, held by Digestive Care Inc. Pancrelipase (Amylase;Lipase;Protease).
As of Nov 13, 2026, BLA 22175 (Pertzye), held by Digestive Care Inc, was first approved by FDA on May 17, 2012, with 6 approved supplements and 0 published complete response letters.
PERTZYE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 17, 2012 | Original applicationTYPE 7 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pertzye30,250USP UNITS;8,000USP UNITS;28,750USP UNITS · capsule, delayed release;oral | Pancrelipase (Amylase;Lipase;Protease) | Rx |
| Pertzye60,500USP UNITS;16,000USP UNITS;57,500USP UNITS · capsule, delayed release;oral | Pancrelipase (Amylase;Lipase;Protease) | Rx |
| Pertzye15,125USP UNITS;4,000USP UNITS;14,375USP UNITS · capsule, delayed release;oral | Pancrelipase (Amylase;Lipase;Protease) | Rx |
| Pertzye90,750USP UNITS;24,000USP UNITS;86,250USP UNITS · capsule, delayed release;oral | Pancrelipase (Amylase;Lipase;Protease) | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2024 | Supplement 10Labeling · Standard review | Approved | |
| Sep 28, 2022 | Supplement 8Labeling · Standard review | Approved | |
| Mar 20, 2020 | Supplement 6Labeling · Standard review | Approved | |
| Jul 12, 2017 | Supplement 4Labeling · Standard review | Approved | |
| Oct 6, 2016 | Supplement 3Manufacturing | Approved | |
| Jan 23, 2014 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| May 17, 2012 | Original applicationTYPE 7 · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
