Pristiq

Treats major depressive disorder (MDD). NDA 21992, held by Pf Prism Cv. Desvenlafaxine Succinate.

As of Nov 14, 2026, NDA 21992 (Pristiq), held by Pf Prism Cv, was first approved by FDA on Feb 29, 2008, with 32 approved supplements and 0 published complete response letters.

First approved: Feb 29, 2008
Review: Standard
Supplements approved: 32
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below


Feb 6, 2018	Supplement 42Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Aug 20, 2014	Supplement 39New molecular entity · Standard review	Approved	Label Letter
Feb 14, 2013	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 29, 2008	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


PristiqEQ 50MG BASE · tablet, extended release;oral	Desvenlafaxine Succinate	RxReference drug
PristiqEQ 100MG BASE · tablet, extended release;oral	Desvenlafaxine Succinate	RxReference drug
PristiqEQ 25MG BASE · tablet, extended release;oral	Desvenlafaxine Succinate	RxReference drug

All 33 submissions, including labeling and manufacturing supplements


Aug 18, 2023	Supplement 51Labeling · Standard review	Approved	Letter Label
Nov 10, 2021	Supplement 47Labeling · Standard review	Approved	Letter Label
Sep 20, 2021	Supplement 48Labeling	Approved	Letter Label
Feb 6, 2018	Supplement 42Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Dec 19, 2017	Supplement 46Labeling	Approved	Letter Label
Jan 4, 2017	Supplement 44Labeling	Approved	Label
Aug 26, 2016	Supplement 43Labeling	Approved	Letter Label
Mar 16, 2016	Supplement 41Manufacturing · Standard review	Approved	None posted
Aug 20, 2014	Supplement 39New molecular entity · Standard review	Approved	Label Letter
Jul 17, 2014	Supplement 40Labeling	Approved	Label Letter
Dec 23, 2013	Supplement 37Labeling · Standard review	Approved	Letter Label
Dec 10, 2013	Supplement 31Labeling · Standard review	Approved	Letter Label
Apr 19, 2013	Supplement 35Manufacturing · Standard review	Approved	None posted
Feb 14, 2013	Supplement 36Labeling · Standard review	Approved	Letter Label
Feb 14, 2013	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 7, 2012	Supplement 34Labeling · Standard review	Approved	Letter Label
Mar 7, 2012	Supplement 30Labeling · Standard review	Approved	Letter Label
Apr 11, 2011	Supplement 22Labeling · Standard review	Approved	Letter Label
Mar 4, 2011	Supplement 21Labeling · Standard review	Approved	Letter Label
Jan 31, 2011	Supplement 20Labeling · Standard review	Approved	Letter Label
Dec 29, 2010	Supplement 19Labeling · Standard review	Approved	Letter Label
Oct 18, 2010	Supplement 13Labeling	Approved	Letter Label
Sep 8, 2010	Supplement 17Labeling · Standard review	Approved	Label Letter
Jul 9, 2010	Supplement 15Labeling	Approved	Letter Label
Feb 16, 2010	Supplement 11Labeling	Approved	Letter Label
Nov 9, 2009	Supplement 9Labeling	Approved	Letter Label
Nov 9, 2009	Supplement 8Labeling	Approved	Letter
Aug 31, 2009	Supplement 7Labeling · Standard review	Approved	Letter Label
Aug 31, 2009	Supplement 6Labeling · Standard review	Approved	Letter Label
Aug 31, 2009	Supplement 1Labeling · Standard review	Approved	Letter Label
Apr 23, 2009	Supplement 5Manufacturing	Approved	Letter Label
Jan 30, 2009	Supplement 4Labeling · Standard review	Approved	Label Letter
Feb 29, 2008	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21992
Drugs@FDA: Overview at FDA
Company: PF PRISM CV

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters