Hylenex Recombinant

BLA 21859, held by Halozyme Therap. Hyaluronidase Recombinant Human.

As of Nov 13, 2026, BLA 21859 (Hylenex Recombinant), held by Halozyme Therap, was first approved by FDA on Dec 2, 2005, with 14 approved supplements and 0 published complete response letters.

First approved: Dec 2, 2005
Review: Priority
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. Indications and Usage HYLENEX recombinant is an endoglycosidase indicated as an adjuvant in subcutaneous fluid administration for achieving hydration to increase the dispersion and absorption of other injected drugs in subcutaneous urography for improving resorption of radiopaque agents 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Dec 2, 2005	Original applicationNew molecular entity · Priority review	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hylenex Recombinant150 UNITS/ML · injectable;injection	Hyaluronidase Recombinant Human	Rx

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 12, 2024	Supplement 31Labeling · Standard review	Approved	Label Letter
Jul 28, 2016	Supplement 24Manufacturing · Priority review	Approved	None posted
Jun 21, 2016	Supplement 25Manufacturing · Priority review	Approved	None posted
Jan 21, 2016	Supplement 23Labeling · Standard review	Approved	Letter Label
Jul 27, 2015	Supplement 22Manufacturing · Priority review	Approved	None posted
Apr 17, 2015	Supplement 21Manufacturing · Priority review	Approved	None posted
Oct 16, 2014	Supplement 19Manufacturing · Priority review	Approved	None posted
May 6, 2014	Supplement 20Manufacturing · Priority review	Approved	None posted
Jul 23, 2013	Supplement 18Manufacturing · Priority review	Approved	None posted
Mar 20, 2012	Supplement 15Labeling	Approved	Letter Label
Mar 1, 2012	Supplement 9Labeling	Approved	Letter Label
Dec 11, 2009	Supplement 6Labeling · Standard review	Approved	Letter Label
Oct 1, 2008	Supplement 5Labeling · Standard review	Approved	Label Letter
Jun 9, 2006	Supplement 2Labeling · Standard review	Approved	Letter
Dec 2, 2005	Original applicationNew molecular entity · Priority review	Approved	Letter Label Review

Identifiers

Application: BLA 21859
Drugs@FDA: Overview at FDA
Company: Halozyme Therapeutics

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