Synvisc and Synvisc-One
FDA premarket approval P940015/S050 · decided 2022-11-04
Approval details
- PMA number
- P940015
- Supplement
- S050
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Synvisc and Synvisc-One
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 2022-09-30
- Decision date
- 2022-11-04
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Approval for revisions of the Synvisc® and Synvisc-One® physician labeling to include a warning statement regarding skin necrosis and the Synvisc® and Synvisc-One® patient labeling to include an advisory for the patient to inform his/her doctor in the event of development of a skin disorder after treatment.
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