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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761156
Company: NOVO NORDISK INC

Products on BLA 761156

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOGROYA	SOMAPACITAN-BECO	10MG/1.5ML	SOLUTION;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761156

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/28/2020	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761156s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761156Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761156Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/27/2026	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761156s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761156Orig1s012, 761156Orig1s014, 761156Orig1s015ltr.pdf
02/27/2026	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761156s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761156Orig1s012, 761156Orig1s014, 761156Orig1s015ltr.pdf
07/09/2025	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761156s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761156Orig1s013ltr.pdf
02/27/2026	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761156s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761156Orig1s012, 761156Orig1s014, 761156Orig1s015ltr.pdf
01/31/2025	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761156s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761156Orig1s006ltr.pdf
04/28/2023	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761156s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761156Orig1s005ltr.pdf
10/01/2021	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761156s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761156Orig1s001, s002ltr.pdf
10/01/2021	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761156s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761156Orig1s001, s002ltr.pdf

Labels for BLA 761156

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/27/2026	SUPPL-15	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761156s015lbl.pdf
02/27/2026	SUPPL-14	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761156s014lbl.pdf
02/27/2026	SUPPL-12	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761156s012lbl.pdf
07/09/2025	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761156s013lbl.pdf
07/09/2025	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761156s013lbl.pdf
01/31/2025	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761156s006lbl.pdf
01/31/2025	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761156s006lbl.pdf
04/28/2023	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761156s005lbl.pdf
10/01/2021	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761156s001s002lbl.pdf
10/01/2021	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761156s001s002lbl.pdf
10/01/2021	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761156s001s002lbl.pdf
10/01/2021	SUPPL-1	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761156s001s002lbl.pdf
08/28/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761156s000lbl.pdf

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