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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 022523
Company: VIVUS INC

Medication Guide

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

Summary Review

Products on BLA 022523

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PANCREAZE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	24,600USP UNITS; 4,200USP UNITS; 14,200USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
PANCREAZE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	61,500USP UNITS; 10,500USP UNITS; 35,500USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
PANCREAZE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	98,400USP UNITS; 16,800USP UNITS; 56,800USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
PANCREAZE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	83,900USP UNITS; 21,000USP UNITS; 54,700USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
PANCREAZE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	149,900USP UNITS; 37,000USP UNITS; 97,300USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No
PANCREAZE	PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)	15,200USP UNITS; 2,600USP UNITS; 8,800USP UNITS	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 022523

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/2010	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022523lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022523s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022523_pancreaze_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022523Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2024	SUPPL-19	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022523s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022523Orig1s019ltr.pdf
04/26/2021	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022523s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022523Orig1s016Corrected_ltr.pdf
01/28/2020	SUPPL-14	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022523s014lbl.pdf
03/20/2020	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022523Orig1s013ltr.pdf
08/04/2016	SUPPL-10	Supplement		Label is not available on this site.
03/30/2015	SUPPL-9	Supplement		Label is not available on this site.
03/03/2015	SUPPL-8	Supplement		Label is not available on this site.
05/16/2016	SUPPL-7	Supplement		Label is not available on this site.
06/23/2014	SUPPL-6	Supplement		Label is not available on this site.
05/27/2014	SUPPL-5	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s005lbl.pdf
03/07/2014	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022523Orig1s004ltr.pdf
12/07/2012	SUPPL-3	Supplement		Label is not available on this site.
06/20/2011	SUPPL-2	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022523s002ltr.pdf

Labels for BLA 022523

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2024	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022523s019lbl.pdf
04/26/2021	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022523s016lbl.pdf
03/20/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf
03/20/2020	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf
01/28/2020	SUPPL-14	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022523s014lbl.pdf
05/27/2014	SUPPL-5	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s005lbl.pdf
03/07/2014	SUPPL-4	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s004lbl.pdf
04/12/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022523lbl.pdf

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