NUXFLEXXA (SODIUM HYALURONATE)
FDA premarket approval P010029/S001 · decided 2006-02-27
Approval details
- PMA number
- P010029
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Trade name
- NUXFLEXXA (SODIUM HYALURONATE)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ferring Pharmaceuticals, Inc.
- Date received
- 2005-01-13
- Decision date
- 2006-02-27
- Days to decision
- 410 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR 1) CHANGING THE STORAGE CONDITIONS SPECIFIED IN THE PRODUCT LABELING FROM, ?STORE IN A COLD DARK PLACE [2 ? 8 DEGREES C (36-46 DEGREES F)]. PROTECT FROM LIGHT. DO NOT FREEZE?. 2) CHANGE THE SPECIFIED SHELF LIFE TIME IN THE LABELING FORM 3 YEARS (AT REFRIGERATED TEMPERATURES) TO 12 MONTHS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EUFLEXXA AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATE
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