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Xolair PFS

omalizumab · Injection, Solution

Prescription BLA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Xolair PFS
Generic name
omalizumab
Dosage form
Injection, Solution
Route
Subcutaneous
Marketing category
BLA · BLA
Labeler
Genentech, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
8
Data completeness
46% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Omalizumab 150 mg/mL 1657209 View
Omalizumab 75 mg/.5mL 1657209 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Subcutaneous
Presentations
10

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Anti-IgE [EPC] EPC 3 members — no class page
Decreased IgE Activity [PE] PE 3 members — no class page
IgE-directed Antibody Interactions [MoA] MoA 3 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
103976
Application type
BLA · Biologics License Application
Approval date
June 20, 2003
Sponsor
GENENTECH
Products on application
4
Submissions recorded
21
Products approved under application 103976.
Product Trade name Form Strength Ingredient Status TE Flags
103976-001 XOLAIR VIAL OMALIZUMAB Prescription —
103976-002 XOLAIR SYRINGE OMALIZUMAB Prescription —
103976-003 XOLAIR SYRINGE OMALIZUMAB Prescription —
103976-004 XOLAIR SYRINGE OMALIZUMAB Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 103976.
Type No. Action Status Date Review
Supplement 5253 Labeling Approved August 6, 2026 Standard
Supplement 5245 Efficacy Approved February 16, 2024 Priority
Supplement 5242 Manufacturing (CMC) Approved August 17, 2023 Unknown
Supplement 5243 Labeling Approved March 17, 2023 Standard
Supplement 5239 Manufacturing (CMC) Approved July 22, 2021 Standard
Supplement 5238 Efficacy Approved April 9, 2021 Standard
Supplement 5235 Efficacy Approved November 30, 2020 Standard
Supplement 5234 Labeling Approved May 1, 2019 Standard
Supplement 5231 Efficacy Approved September 28, 2018 Priority
Supplement 5225 Efficacy Approved July 6, 2016 Standard
Supplement 5224 Labeling Approved December 3, 2015 Standard
Supplement 5161 Efficacy Approved September 26, 2014 Standard
Supplement 5211 Efficacy Approved March 21, 2014 Standard
Supplement 5191 Labeling Approved December 22, 2011 Standard
Supplement 5180 Labeling Approved December 21, 2010 Standard
Supplement 5165 Labeling Approved July 30, 2010 Standard
Supplement 5166 Efficacy Approved January 4, 2010 Standard
Supplement 5154 Labeling Approved July 24, 2009 Standard
Supplement 5102 Labeling Approved July 2, 2007 Standard
Supplement 5087 Supplement Approved April 7, 2006 —
Original application 1 Type 1 - New Molecular Entity Approved June 20, 2003 Standard

Review documents

  • 0 · Supplement · August 11, 2026
  • 0 · Supplement · August 11, 2026
  • 0 · Supplement · August 10, 2026
  • 0 · Supplement · February 20, 2024
  • 0 · Supplement · February 16, 2024
  • 0 · Supplement · November 16, 2023
  • 0 · Supplement · May 3, 2023
  • 0 · Supplement · March 20, 2023
  • 0 · Supplement · March 18, 2022
  • 0 · Supplement · March 18, 2022
  • 0 · Supplement · April 13, 2021
  • 0 · Supplement · April 12, 2021
  • 0 · Supplement · January 7, 2021
  • 0 · Supplement · January 7, 2021
  • 0 · Supplement · December 2, 2020
  • 0 · Supplement · December 1, 2020
  • 0 · Supplement · May 2, 2019
  • 0 · Supplement · May 2, 2019
  • 0 · Supplement · October 3, 2018
  • 0 · Supplement · October 1, 2018
  • 0 · Supplement · July 8, 2016
  • 0 · Supplement · July 7, 2016
  • 0 · Supplement · December 8, 2015
  • 0 · Supplement · December 8, 2015
  • 0 · Supplement · October 1, 2014
  • 0 · Supplement · September 30, 2014
  • 0 · Supplement · March 25, 2014
  • 0 · Supplement · March 25, 2014
  • 0 · Supplement · January 5, 2012
  • 0 · Supplement · January 10, 2011

Adverse event reports

Source: openFDA FAERS
84,758
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: OMALIZUMAB. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
50242-214-03 50242-214 Genentech, Inc. 1 SYRINGE, GLASS in 1 CARTON (50242-214-03) / .5 mL in 1 SYRINGE, GLASS August 18, 2023
50242-214-55 50242-214 Genentech, Inc. 1 SYRINGE, GLASS in 1 CARTON (50242-214-55) / .5 mL in 1 SYRINGE, GLASS August 18, 2023
50242-214-83 50242-214 Genentech, Inc. 1 SYRINGE, GLASS in 1 CARTON (50242-214-83) / .5 mL in 1 SYRINGE, GLASS August 18, 2023
50242-214-99 50242-214 Genentech, Inc. 1 SYRINGE, GLASS in 1 CARTON (50242-214-99) / .5 mL in 1 SYRINGE, GLASS August 18, 2023
50242-215-03 50242-215 Genentech, Inc. 1 SYRINGE, GLASS in 1 CARTON (50242-215-03) / 1 mL in 1 SYRINGE, GLASS August 18, 2023
50242-215-55 50242-215 Genentech, Inc. 1 SYRINGE, GLASS in 1 CARTON (50242-215-55) / 1 mL in 1 SYRINGE, GLASS August 18, 2023
50242-215-83 50242-215 Genentech, Inc. 1 SYRINGE, GLASS in 1 CARTON (50242-215-83) / 1 mL in 1 SYRINGE, GLASS August 18, 2023
50242-215-99 50242-215 Genentech, Inc. 1 SYRINGE, GLASS in 1 CARTON (50242-215-99) / 1 mL in 1 SYRINGE, GLASS August 18, 2023
50242-214 50242-214 Genentech, Inc. — September 28, 2018
50242-215 50242-215 Genentech, Inc. — September 28, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 9 sections on this page.