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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 022458
Company: PFIZER

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 022458

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELELYSO	TALIGLUCERASE ALFA	200 UNITS/VIAL	POWDER;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 022458

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2012	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022458lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022458s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022458Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/09/2023	SUPPL-30	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022458s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022458Orig1s030ltr.pdf
08/30/2022	SUPPL-29	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022458s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022458Orig1s029ltr.pdf
11/03/2020	SUPPL-24	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022458s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022458Orig1s024ltr.pdf
10/21/2019	SUPPL-23	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022458s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022458Orig1s023ltr.pdf
12/20/2016	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022458s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/22458Orig1s013ltr.pdf
06/15/2016	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022458s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022458Orig1s012ltr.pdf
12/23/2015	SUPPL-8	Supplement		Label is not available on this site.
11/20/2015	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022458s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022458Orig1s007ltr.pdf
08/27/2014	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s003s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022458Orig1s003,022458Orig1s006ltr.pdf
02/25/2016	SUPPL-5	Supplement		Label is not available on this site.
06/24/2014	SUPPL-4	Supplement		Label is not available on this site.
08/27/2014	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s003s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022458Orig1s003,022458Orig1s006ltr.pdf
05/14/2014	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022458Orig1s002ltr.pdf
01/13/2014	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 022458

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/09/2023	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022458s030lbl.pdf
08/30/2022	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022458s029lbl.pdf
08/30/2022	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022458s029lbl.pdf
11/03/2020	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022458s024lbl.pdf
11/03/2020	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022458s024lbl.pdf
10/21/2019	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022458s023lbl.pdf
12/20/2016	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022458s013lbl.pdf
06/15/2016	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022458s012lbl.pdf
11/20/2015	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022458s007lbl.pdf
08/27/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s003s006lbl.pdf
08/27/2014	SUPPL-3	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s003s006lbl.pdf
05/14/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s002lbl.pdf
05/01/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022458lbl.pdf

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