FDA Purple Book · Reference family
Azficel-T (Laviv)
Azficel-T is an FDA-licensed reference biologic from Fibrocell Technologies, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2011
Reference approved
Reference product
351(a)BLA 125348
Laviv Azficel-T
Fibrocell Technologies, Inc.
- Approved
- Jun 21, 2011
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Azficel-T, in chronological order.
Reference approval
Approval date of the reference Azficel-T product.
15 yr 2 mo ago
Frequently asked questions
Are there biosimilars approved for Azficel-T (Laviv)?
No 351(k) biosimilars or interchangeable biosimilars referencing Azficel-T are listed in the FDA Purple Book yet.
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