EUFLEXXA (1% SODIUM HYALURONATE)
FDA premarket approval P010029 · decided 2004-12-03
Approval details
- PMA number
- P010029
- Trade name
- EUFLEXXA (1% SODIUM HYALURONATE)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ferring Pharmaceuticals, Inc.
- Date received
- 2001-05-01
- Decision date
- 2004-12-03
- Days to decision
- 1312 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR NUFLEXXA (1% SODIUM HYALURONATE). THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
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