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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022580
Company: VIVUS

Medication Guide

REMS

Summary Review

Products on NDA 022580

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QSYMIA	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
QSYMIA	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
QSYMIA	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
QSYMIA	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022580

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/17/2012	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022580Origs000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000_qsymia_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2023	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022580s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022580Orig1s023ltr.pdf
05/09/2023	SUPPL-22	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022580Orig1s022ltr.pdf
06/24/2022	SUPPL-21	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022580s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022580Orig1s021ltr.pdf
03/08/2022	SUPPL-20	REMS - MODIFIED - D-N-A	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022580Orig1s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/022580Orig1s020.pdf
03/31/2021	SUPPL-19	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022580s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022580Orig1s019ltr.pdf
10/19/2020	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022580s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022580Orig1s017ltr.pdf
03/23/2018	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022580s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022580rig1s016ltr.pdf
01/27/2017	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
09/26/2014	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s012ltr.pdf
09/26/2014	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s012ltr.pdf
09/26/2014	SUPPL-10	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s012ltr.pdf
09/24/2013	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/17/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/19/2013	SUPPL-5	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s005lbl.pdf
04/16/2013	SUPPL-4	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022580Orig1s004ltr.pdf
11/01/2012	SUPPL-1	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022580Orig1s001ltr.pdf

Labels for NDA 022580

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2023	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022580s023lbl.pdf
06/24/2022	SUPPL-21	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022580s021lbl.pdf
03/31/2021	SUPPL-19	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022580s019lbl.pdf
10/19/2020	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022580s017lbl.pdf
10/19/2020	SUPPL-17	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022580s017lbl.pdf
03/23/2018	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022580s016lbl.pdf
03/23/2018	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022580s016lbl.pdf
09/26/2014	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf
09/26/2014	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf
09/26/2014	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf
09/26/2014	SUPPL-10	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf
04/16/2013	SUPPL-4	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s004lbl.pdf
03/19/2013	SUPPL-5	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s005lbl.pdf
11/01/2012	SUPPL-1	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s001lbl.pdf
07/17/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s000lbl.pdf

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