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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761166
Company: PHARMAESSENTIA CORP

Medication Guide

Products on BLA 761166

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BESREMI	ROPEGINTERFERON ALFA-2B-NJFT	500 MCG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761166

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/12/2021	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761166s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761166Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761166Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/28/2026	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761166s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761166Orig1s03ltr.pdf
06/26/2026	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761166s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761166Orig1s010ltr.pdf
04/29/2024	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761166s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761166Orig1s007ltr.pdf
05/25/2023	SUPPL-3	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761166Orig1s003ltr.pdf

Labels for BLA 761166

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/28/2026	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761166s013lbl.pdf
06/26/2026	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761166s010lbl.pdf
04/29/2024	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761166s007lbl.pdf
11/12/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761166s000lbl.pdf

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