EUFLEXXA (1% Sodium Hyaluronate)
FDA premarket approval P010029/S025 · decided 2017-12-28
Approval details
- PMA number
- P010029
- Supplement
- S025
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EUFLEXXA (1% Sodium Hyaluronate)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ferring Pharmaceuticals, Inc.
- Date received
- 2017-06-20
- Decision date
- 2017-12-28
- Days to decision
- 191 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for BTG (Ferring) to manufacture, package and release Euflexxa at both the BTG (Ferring) and Lifecore facilities.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.