allogenic thymocyte-depleted thymus tissue-agdc

FDA Drug Profile — RETHYMIC

Drug Details

Generic Name
allogenic thymocyte-depleted thymus tissue-agdc
Brand Names
RETHYMIC
Application Number
BLA125685
Sponsor
Sumitomo Pharma America, Inc.
NDC Codes
1
Dosage Forms
IMPLANT
Routes
INTRAMUSCULAR
Active Ingredients
ALLOGENEIC THYMOCYTE-DEPLETED THYMUS TISSUE-AGDC

Indications and Usage

1 INDICATIONS AND USAGE RETHYMIC ® is indicated for immune reconstitution in pediatric patients with congenital athymia. RETHYMIC is indicated for immune reconstitution in pediatric patients with congenital athymia. ( 1 ) Limitations of Use : RETHYMIC is not indicated for the treatment of patients with severe combined immunodeficiency (SCID). Limitations of Use RETHYMIC is not indicated for the treatment of patients with severe combined immunodeficiency (SCID).