EUFLEXXA 1% SODIUM HYALURONATE
FDA premarket approval P010029/S007 · decided 2009-07-01
Approval details
- PMA number
- P010029
- Supplement
- S007
- Supplement type
- 135 Review Track For 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
- 2008-05-02
- Decision date
- 2009-07-01
- Days to decision
- 425 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR THE STERILE SODIUM HYALURONATE (NAHA) TO BE STORED IN STERILE, DISPOSABLE POLYETHYLENE BAGS FOR UP TO 48 HOURS PRIOR TO FILLING THE SYRINGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EUFLEXXA AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
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