somatrogon-ghla

FDA Drug Profile — Ngenla

Drug Details

Generic Name
somatrogon-ghla
Brand Names
Ngenla
Application Number
BLA761184
Sponsor
Pfizer Laboratories Div Pfizer Inc
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
SOMATROGON

Indications and Usage

1 INDICATIONS AND USAGE NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone. NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone ( 1 ).