EUFLEXXA (1% SODIUM HYALURONATE)
FDA premarket approval P010029/S008 · decided 2011-10-11
Approval details
- PMA number
- P010029
- Supplement
- S008
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EUFLEXXA (1% SODIUM HYALURONATE)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ferring Pharmaceuticals, Inc.
- Date received
- 2009-03-30
- Decision date
- 2011-10-11
- Days to decision
- 925 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR EUFLEXXA (1% SODIUM HYALURONATE). THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVENON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
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