Deoxycholic Acid

FDA Drug Profile — KYBELLA

Drug Details

Generic Name
Deoxycholic Acid
Brand Names
KYBELLA
Application Number
NDA206333
Sponsor
Sterling Pharma Solutions Limited
NDC Codes
2
Dosage Forms
POWDER, INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
DEOXYCHOLIC ACID

Indications and Usage

1 INDICATIONS AND USAGE KYBELLA ® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. Limitations of use The safe and effective use of KYBELLA for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended. KYBELLA is a cytolytic drug indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. ( 1 ) Limit ation s of use The safe and effective use of KYBELLA for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended. ( 1 )