triamcinolone acetonide extended-release injectable suspension

FDA Drug Profile — Zilretta

Drug Details

Generic Name
triamcinolone acetonide extended-release injectable suspension
Brand Names
Zilretta
Application Number
NDA208845
Sponsor
Pacira Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
KIT
Routes
INTRA-ARTICULAR
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. ZILRETTA is an extended-release synthetic corticosteroid indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. ( 1 ) Limitation of Use The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. ( 2.1 ) Limitation of Use The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. [see Dosage and Administration (2.1) ] .