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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210922
Company: ALNYLAM PHARMS INC

Products on NDA 210922

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONPATTRO	PATISIRAN SODIUM	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210922

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/10/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210922s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210922Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210922Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/03/2022	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210922s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210922Orig1s013ltr.pdf
01/13/2023	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210922s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210922Orig1s012ltr.pdf
05/06/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210922s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210922Orig1s009ltr.pdf
04/17/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210922s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210922Orig1s007ltr.pdf
09/16/2019	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210922s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210922Orig1s004ltr.pdf
05/06/2019	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210922Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210922s001ltr.pdf

Labels for NDA 210922

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2023	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210922s012lbl.pdf
10/03/2022	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210922s013lbl.pdf
05/06/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210922s009lbl.pdf
04/17/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210922s007lbl.pdf
09/16/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210922s004lbl.pdf
05/06/2019	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210922Orig1s001lbl.pdf
08/10/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210922s000lbl.pdf

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