Lonapegsomatropin-tcgd

FDA Drug Profile — Skytrofa

Drug Details

Generic Name
Lonapegsomatropin-tcgd
Brand Names
Skytrofa
Application Number
BLA761177
Sponsor
Ascendis Pharma Endocrinology, Inc.
NDC Codes
14
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
LONAPEGSOMATROPIN

Indications and Usage

1 INDICATIONS AND USAGE SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH). Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD). SKYTROFA is a human growth hormone indicated for: Pediatric Patients: Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH) ( 1 ). Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD) ( 1 ).