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Medicines · US (FDA)

FDA 2021

Somatropin and somatropin agonists

Skytrofa

Approved 25 Aug 2021InjectionInjectable

The FDA lists this product in 9 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: LONAPEGSOMATROPIN-TCGD 4.3MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

LONAPEGSOMATROPIN-TCGD 3MG · InjectableBLA761177-001 · Prescription
LONAPEGSOMATROPIN-TCGD 11MG · InjectableBLA761177-008 · Prescription
LONAPEGSOMATROPIN-TCGD 7.6MG · InjectableBLA761177-006 · Prescription
LONAPEGSOMATROPIN-TCGD 5.2MG · InjectableBLA761177-004 · Prescription
LONAPEGSOMATROPIN-TCGD 3.6MG · InjectableBLA761177-002 · Prescription
LONAPEGSOMATROPIN-TCGD 13.3MG · InjectableBLA761177-009 · Prescription
LONAPEGSOMATROPIN-TCGD 9.1MG · InjectableBLA761177-007 · Prescription
LONAPEGSOMATROPIN-TCGD 6.3MG · InjectableBLA761177-005 · Prescription
LONAPEGSOMATROPIN-TCGD 4.3MG · InjectableThis page

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application BLA761177.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Skytrofa
Active substance: lonapegsomatropin-tcgd
Drug class: Somatropin and somatropin agonists
Route: Injection
Dosage form: Injectable
Applicant: Ascendis Pharma Encocrinology Div A/S
Status: Prescription
FDA approval: 25 Aug 2021
Application: BLA761177-003
RxCUI: 2569597