Leniolisib

FDA Drug Profile — Joenja

Drug Details

Generic Name
Leniolisib
Brand Names
Joenja
Application Number
NDA217759
Sponsor
Pharming Healthcare Inc.
NDC Codes
1
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
LENIOLISIB PHOSPHATE

Indications and Usage

1 INDICATIONS AND USAGE JOENJA is indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older. JOENJA is a kinase inhibitor indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older. ( 1 )