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raxibacumab

Prescription Biologic BLA

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name

Raxibacumab

Generic name

raxibacumab

Dosage form

Injection

Route

Intravenous

Marketing category

BLA · BLA

Labeler

Emergent BioDefense Operations Lansing

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

52% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Raxibacumab	50 mg/mL	—	—

Forms, strengths and routes

Source: NDC Directory

Dosage form

Injection

Route of administration

Intravenous

Presentations

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
Anthrax Protective Antigen-directed Antibody Interactions [MoA]	MoA	1 member — no class page
Anthrax Protective Antigen-directed Antibody [EPC]	EPC	1 member — no class page

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

125349

Application type

BLA · Biologics License Application

Approval date

December 14, 2012

Sponsor

HUMAN GENOME SCIENCES INC.

Products on application

Submissions recorded

Products approved under application 125349.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
125349-001	RAXIBACUMAB	INJECTABLE		RAXIBACUMAB	Prescription	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 125349.
Type	No.	Action	Status	Date	Review
Supplement	26	Labeling	Approved	June 2, 2021	Standard
Supplement	22	Efficacy	Approved	January 11, 2018	Priority
Original application	1	Type 1 - New Molecular Entity	Approved	December 14, 2012	Priority

Review documents

0 · Supplement · June 3, 2021
0 · Supplement · June 3, 2021
0 · Supplement · June 3, 2021
0 · Supplement · January 17, 2018
0 · Original application · January 25, 2013
0 · Original application · January 25, 2013
0 · Original application · December 27, 2012
0 · Original application · December 27, 2012

Adverse event reports

Source: openFDA FAERS

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.

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
71655-103-01	71655-103	Emergent BioDefense Operations Lansing	1 VIAL, SINGLE-USE in 1 CARTON (71655-103-01) / 34 mL in 1 VIAL, SINGLE-USE	December 14, 2012
71655-103	71655-103	Emergent BioDefense Operations Lansing	—	December 14, 2012

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
Purple Book	FDA	Biologic licence classification

Generated September 25, 2026 · 8 sections on this page.