An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
02/06/2024	SUPPL-24	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022580Orig1s024ltr.pdf
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-Medication Guide, Labeling-Package Insert	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-Medication Guide, Labeling-Package Insert	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-Package Insert, Labeling-Medication Guide	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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022580s017lbl.pdf
10/19/2020	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022580s017lbl.pdf
03/23/2018	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022580s016lbl.pdf
03/23/2018	SUPPL-16	Labeling-Package Insert	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-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-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

Top