Adagen

BLA 19818, held by Leadiant Biosci Inc. Pegademase Bovine.

As of Nov 13, 2026, BLA 19818 (Adagen), held by Leadiant Biosci Inc, was first approved by FDA on Mar 21, 1990, with 25 approved supplements and 0 published complete response letters.

First approved: Mar 21, 1990
Review: Priority
Supplements approved: 25
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Mar 21, 1990	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Adagen250 UNITS/ML · injectable;injection	Pegademase Bovine	Discontinued

All 26 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 21, 2015	Supplement 56Manufacturing · Priority review	Approved	None posted
Jul 17, 2014	Supplement 55Manufacturing · Priority review	Approved	None posted
Jun 5, 2014	Supplement 53Labeling · Standard review	Approved	Letter Label
Mar 4, 2014	Supplement 52Manufacturing · Priority review	Approved	None posted
Jan 10, 2014	Supplement 50Manufacturing · Priority review	Approved	None posted
Dec 17, 2013	Supplement 51Manufacturing · Priority review	Approved	None posted
Oct 15, 2013	Supplement 48Manufacturing · Priority review	Approved	None posted
Oct 7, 2013	Supplement 47Manufacturing · Priority review	Approved	None posted
Jan 15, 2013	Supplement 46Manufacturing · Priority review	Approved	None posted
Sep 25, 2008	Supplement 42Labeling · Standard review	Approved	Letter Label
Oct 26, 2007	Supplement 34Labeling · Standard review	Approved	Letter Label
Apr 15, 2002	Supplement 24Manufacturing · Priority review	Approved	None posted
Aug 17, 2001	Supplement 23Manufacturing · Priority review	Approved	None posted
Sep 16, 1998	Supplement 17Manufacturing · Priority review	Approved	None posted
Jun 16, 1994	Supplement 13Manufacturing · Priority review	Approved	None posted
Dec 6, 1993	Supplement 14Manufacturing · Priority review	Approved	None posted
Aug 11, 1993	Supplement 11Manufacturing · Priority review	Approved	None posted
Mar 9, 1993	Supplement 7Manufacturing · Priority review	Approved	None posted
Dec 28, 1992	Supplement 8Manufacturing · Priority review	Approved	None posted
Nov 10, 1992	Supplement 9Labeling · Standard review	Approved	None posted
Apr 22, 1992	Supplement 5Manufacturing · Priority review	Approved	None posted
Apr 13, 1992	Supplement 4Manufacturing · Priority review	Approved	None posted
Sep 27, 1991	Supplement 3Labeling	Approved	None posted
Jun 10, 1991	Supplement 2Manufacturing · Priority review	Approved	None posted
Nov 28, 1990	Supplement 1Manufacturing · Priority review	Approved	None posted
Mar 21, 1990	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: BLA 19818
Drugs@FDA: Overview at FDA
Company: Leadiant Biosciences

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