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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761177
Company: ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S

Products on BLA 761177

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SKYTROFA	LONAPEGSOMATROPIN-TCGD	3MG	INJECTABLE;INJECTION	Prescription	None	No	No
SKYTROFA	LONAPEGSOMATROPIN-TCGD	3.6MG	INJECTABLE;INJECTION	Prescription	None	No	No
SKYTROFA	LONAPEGSOMATROPIN-TCGD	4.3MG	INJECTABLE;INJECTION	Prescription	None	No	No
SKYTROFA	LONAPEGSOMATROPIN-TCGD	5.2MG	INJECTABLE;INJECTION	Prescription	None	No	No
SKYTROFA	LONAPEGSOMATROPIN-TCGD	6.3MG	INJECTABLE;INJECTION	Prescription	None	No	No
SKYTROFA	LONAPEGSOMATROPIN-TCGD	7.6MG	INJECTABLE;INJECTION	Prescription	None	No	No
SKYTROFA	LONAPEGSOMATROPIN-TCGD	9.1MG	INJECTABLE;INJECTION	Prescription	None	No	No
SKYTROFA	LONAPEGSOMATROPIN-TCGD	11MG	INJECTABLE;INJECTION	Prescription	None	No	No
SKYTROFA	LONAPEGSOMATROPIN-TCGD	13.3MG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761177

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/2021	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761177Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761177Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761177Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/09/2025	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761177s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761177Orig1s009ltr.pdf
07/25/2025	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761177s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761177Orig1s008ltr.pdf
10/20/2022	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761177s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761177Orig1s001ltr.pdf

Labels for BLA 761177

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2025	SUPPL-8	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761177s008lbl.pdf
07/09/2025	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761177s009lbl.pdf
10/20/2022	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761177s001lbl.pdf
08/25/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761177Orig1s000lbl.pdf

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