EUFLEXXA
FDA premarket approval P010029/S037 · decided 2024-03-01
Approval details
- PMA number
- P010029
- Supplement
- S037
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EUFLEXXA
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ferring Pharmaceuticals, Inc.
- Date received
- 2024-02-05
- Decision date
- 2024-03-01
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- modifications to the purification process utilized in the manufacturing of NaHA bulk intermediate batches to optimize the ability to remove contaminants and to improve yield. Proposed modifications include increasing the amount of activated charcoal, Celatom and water for injection for the 1 kg and 1.5 kg batch sizes as well as two additional ethanol washes for the 1.5 kg batch size
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