EUFLEXXA
FDA premarket approval P010029/S002 · decided 2005-10-20
Approval details
- PMA number
- P010029
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EUFLEXXA
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ferring Pharmaceuticals, Inc.
- Date received
- 2005-10-05
- Decision date
- 2005-10-20
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR CHANGING THE TRADE NAME O THE PRODUCT FROM NUFLEXXA TO EUFLEXXA. 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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