Tyzeka

NDA 22154, held by Novartis. Telbivudine.

As of Nov 13, 2026, NDA 22154 (Tyzeka), held by Novartis, was first approved by FDA on Apr 28, 2009, with 10 approved supplements and 0 published complete response letters.

First approved: Apr 28, 2009
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Jan 28, 2013	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 28, 2009	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tyzeka100MG/5ML · solution;oral	Telbivudine	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Dec 27, 2018	Supplement 19Labeling · Standard review	Approved	Letter Label Medication Guide
Mar 28, 2018	Supplement 18Labeling · Standard review	Approved	Label Letter
Jan 30, 2014	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 6, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 28, 2013	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 23, 2011	Supplement 9Labeling · Standard review	Approved	Letter Label
May 5, 2011	Supplement 8REMS	Approved	Letter
Mar 29, 2011	Supplement 6Labeling	Approved	Label Letter
Sep 10, 2010	Supplement 3Labeling	Approved	Label Letter
Mar 4, 2010	Supplement 1Labeling · Standard review	Approved	Label Letter
Apr 28, 2009	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 22154
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