somapacitan-beco

FDA Drug Profile — SOGROYA

Drug Details

Generic Name
somapacitan-beco
Brand Names
SOGROYA
Application Number
BLA761156
Sponsor
Novo Nordisk
NDC Codes
3
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
SOMAPACITAN

Indications and Usage

1 INDICATIONS AND USAGE SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: • Growth failure due to inadequate secretion of endogenous growth hormone (GH). • Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age. • Growth failure associated with Noonan syndrome (NS). • Idiopathic Short Stature (ISS). SOGROYA is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD). SOGROYA is a human growth hormone analog indicated for: Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older with: • Growth failure due to inadequate secretion of endogenous growth hormone (GH). ( 1 ) • Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age. ( 1 ) • Growth failure associated with Noonan syndrome (NS). ( 1 ) • Idiopathic Short Stature (ISS). ( 1 ) Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD). ( 1 )