← FDA DRUG APPROVALS

FDA BLA · BLA761177

SKYTROFA

lonapegsomatropin-tcgd

Sponsor: ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S

APPLICATION
BLA761177
TYPE
BLA
ORIGINAL APPROVAL
2021-08-25
LATEST ACTION
2025-07-25
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SKYTROFAPrescription
LONAPEGSOMATROPIN-TCGD 3MG · INJECTABLE · INJECTION
SKYTROFAPrescription
LONAPEGSOMATROPIN-TCGD 11MG · INJECTABLE · INJECTION
SKYTROFAPrescription
LONAPEGSOMATROPIN-TCGD 7.6MG · INJECTABLE · INJECTION
SKYTROFAPrescription
LONAPEGSOMATROPIN-TCGD 5.2MG · INJECTABLE · INJECTION
SKYTROFAPrescription
LONAPEGSOMATROPIN-TCGD 3.6MG · INJECTABLE · INJECTION
SKYTROFAPrescription
LONAPEGSOMATROPIN-TCGD 13.3MG · INJECTABLE · INJECTION
SKYTROFAPrescription
LONAPEGSOMATROPIN-TCGD 9.1MG · INJECTABLE · INJECTION
SKYTROFAPrescription
LONAPEGSOMATROPIN-TCGD 6.3MG · INJECTABLE · INJECTION
SKYTROFAPrescription
LONAPEGSOMATROPIN-TCGD 4.3MG · INJECTABLE · INJECTION

Approval history

2025-07-25Efficacy · Supplement 8 · standard — Letter ↗AP
2025-07-09Labeling · Supplement 9 · standard — Letter ↗AP
2022-10-20Labeling · Supplement 1 · standard — Letter ↗AP
2021-08-25Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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