Is Botulinum toxin type b approved by the US FDA?

Drugs@FDA lists 1 application product line for Botulinum toxin type b, including MYOBLOC (Prescription).

Is Botulinum toxin type b authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Botulinum toxin type b.

Are there safety signals or safety updates for Botulinum toxin type b?

US FDA: 1 entry; MHRA: 1 entry (latest 2021-03-10).

Active substance

Botulinum toxin type b

US FDA 1
EMA 1
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
MYOBLOC	5000IU/VIAL	vial	ELAN PHARM	Prescription	8 Dec 2000

EMA European Union — centrally authorised medicines

NeuroBloc Sloan Pharma S.a.r.l · Withdrawn · authorised 22 Jan 2001 · ATC M03AX01

Therapeutic indication (EMA)

NeuroBloc is indicated for the treatment of cervical dystonia (torticollis). See section 5.1 for data on efficacy in patients responsive / resistant to botulinum toxin type A.

Safety signals and safety-related labeling changes

US FDA 10 Mar 2021 MYOBLOC — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 11 Dec 2014 Botulinum toxin type B (Neurobloc): serious known risks
Risks such as toxin spread reported mostly with off-label use.

All safety entries for botulinum toxin type b →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.