General MedicationsINJECTIONStandard
SKYTROFA
LONAPEGSOMATROPIN-TCGD
Standard Dose
9.1MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview SKYTROFA is listed in Drugs@FDA under application 761177 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LONAPEGSOMATROPIN-TCGD Form and strength INJECTABLE;INJECTION - 9.1MG Sponsor ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S Submission history Latest submission status date: 2025-07-25 00:00:00.
Structured Monograph
Clinical summary
Approval overview SKYTROFA is listed in Drugs@FDA under application 761177 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient LONAPEGSOMATROPIN-TCGD Form and strength INJECTABLE;INJECTION - 9.1MG Sponsor ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S Submission history Latest submission status date: 2025-07-25 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.