Valturna

NDA 22217, held by Novartis. Aliskiren Hemifumarate; Valsartan.

As of Nov 14, 2026, NDA 22217 (Valturna), held by Novartis, was first approved by FDA on Sep 16, 2009, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 16, 2009
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Sep 16, 2009	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


ValturnaEQ 150MG BASE;160MG · tablet;oral	Aliskiren Hemifumarate; Valsartan	Discontinued
ValturnaEQ 300MG BASE;320MG · tablet;oral	Aliskiren Hemifumarate; Valsartan	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Apr 25, 2012	Supplement 20Labeling · Standard review	Approved	Letter Label
Feb 2, 2012	Supplement 17Labeling · Standard review	Approved	Letter Label
Jan 26, 2012	Supplement 16Labeling · Standard review	Approved	Label Letter
Oct 13, 2011	Supplement 14Labeling · Standard review	Approved	Label Letter
May 4, 2011	Supplement 13Labeling · Standard review	Approved	Letter Label
Feb 10, 2011	Supplement 7Labeling · Standard review	Approved	Letter Label
Aug 4, 2010	Supplement 5Labeling · Standard review	Approved	Label Letter
Sep 16, 2009	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22217
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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