Purple Book product · Reference 351(a)

Myobloc

rimabotulinumtoxinB

351(a)BLA 103846RxLicensed Solstice NeuroSciences, LLC

View rimabotulinumtoxinB family Label PDF Open on FDA Purple Book

Dec 08, 2000

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Myobloc (rimabotulinumtoxinB) is Solstice NeuroSciences, LLC's FDA-licensed reference biologic, approved under a 351(a) BLA in 2000. No biosimilars referencing Myobloc are listed in the Purple Book yet.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
Dec 08, 2000
26 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Dec 08, 2007
18 yr 11 mo ago
Today

Pharmaceutical detail

Strength

2,500UNITS/0.5ML

Dosage form

Injection

Route

Intramuscular, Intraglandular

Presentation

Single-Dose Vial

Center

CDER

License number

1718

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.

2 additional BLA records for this product (other strengths or presentations) are in the same reference family.

Patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
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Change history

v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Myobloc have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing Myobloc are listed in the FDA Purple Book yet.

What is Myobloc's BLA number?

Myobloc is licensed under BLA 103846, held by Solstice NeuroSciences, LLC.

When was Myobloc approved by the FDA?

Myobloc was approved by the FDA on Dec 08, 2000.

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