PMA P010029S001

Device

NUXFLEXXA (SODIUM HYALURONATE)

Applicant

Ferring Pharmaceuticals, Inc.

PMA number

P010029

Supplement

S001

Product code

MOZ

Decision date

2006-02-27

Classification

Acid, Hyaluronic, Intraarticular

Generic name

Acid, hyaluronic, intraarticular

Approval order 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 ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN.)

Summary

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