Sucraid

Treats sucrase deficiency. BLA 20772, held by Qol Medcl. Sacrosidase.

As of Nov 13, 2026, BLA 20772 (Sucraid), held by Qol Medcl, was first approved by FDA on Apr 9, 1998, with 15 approved supplements and 0 published complete response letters.

First approved: Apr 9, 1998
Review: Priority
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Sucraid (sacrosidase) Oral Solution is indicated for the treatment of sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID), in adult and pediatric patients 5 months of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Apr 9, 1998	Original applicationNew molecular entity · Priority review	Approved	Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sucraid8,500 IU/ML · solution;oral	Sacrosidase	Rx

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 2, 2024	Supplement 31Labeling · Standard review	Approved	Label Letter
Jul 24, 2024	Supplement 30Labeling · Standard review	Approved	Label Letter
May 25, 2022	Supplement 27Manufacturing	Approved	Letter Label
Sep 21, 2015	Supplement 20Manufacturing · Priority review	Approved	None posted
Feb 16, 2015	Supplement 19Manufacturing · Priority review	Approved	None posted
Dec 2, 2014	Supplement 17Manufacturing · Priority review	Approved	None posted
Nov 7, 2014	Supplement 15Manufacturing · Priority review	Approved	None posted
May 28, 2013	Supplement 13Manufacturing · Priority review	Approved	None posted
Jun 15, 2011	Supplement 8Labeling · Standard review	Approved	Letter
Dec 9, 2010	Supplement 11REMS	Approved	Letter
Nov 20, 2008	Supplement 7Manufacturing · Priority review	Approved	None posted
Nov 20, 2008	Supplement 6Manufacturing	Approved	None posted
Nov 20, 2008	Supplement 5Manufacturing	Approved	Letter
Feb 20, 2008	Supplement 4Manufacturing	Approved	None posted
Nov 3, 2006	Supplement 2Manufacturing	Approved	Letter
Apr 9, 1998	Original applicationNew molecular entity · Priority review	Approved	Letter Review

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: SucraidMay 26, 2026

Identifiers

Application: BLA 20772
Drugs@FDA: Overview at FDA
Company: QOL Medical

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