Pulmozyme

Manages cystic fibrosis (CF). BLA 103532, held by Genentech. Dornase Alfa.

As of Nov 13, 2026, BLA 103532 (Pulmozyme), held by Genentech, was first approved by FDA on Dec 30, 1993, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1993
Review: Priority
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PULMOZYME is indicated, in conjunction with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) to improve pulmonary function. In CF patients with an FVC ≥ 40% of predicted, daily administration of PULMOZYME has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics. PULMOZYME is a recombinant DNase enzyme indicated in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 12, 2014	Supplement 5175Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 24, 1998	Supplement 1025Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 27, 1996	Supplement 1018Efficacy (new indication or use)	Approved	None posted
Dec 30, 1993	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pulmozyme1MG/ML · vial	Dornase Alfa	Rx

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 9, 2024	Supplement 5194Labeling · Standard review	Approved	Review Label Letter
Jul 30, 2021	Supplement 5191Labeling · Standard review	Approved	Label Letter
Dec 12, 2014	Supplement 5175Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 6, 2010	Supplement 5142Labeling · Standard review	Approved	None posted
Dec 20, 1999	Supplement 1030Labeling · Standard review	Approved	None posted
Feb 24, 1998	Supplement 1025Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 27, 1996	Supplement 1018Efficacy (new indication or use)	Approved	None posted
Dec 30, 1993	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: BLA 103532
Drugs@FDA: Overview at FDA
Company: Genentech

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