EUFLEXXA (1% SODIUM HYALURONATE)
FDA premarket approval P010029/S022 · decided 2015-03-12
Approval details
- PMA number
- P010029
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EUFLEXXA (1% SODIUM HYALURONATE)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ferring Pharmaceuticals, Inc.
- Date received
- 2015-02-09
- Decision date
- 2015-03-12
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- PROPOSED SCALE-UP OF MANUFACTURING PROCESSES TO INCREASE PRODUCT YIELD PER LOT FOR THE EUFLEXXA PRODUCT.
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