Tyzeka

NDA 22011, held by Novartis. Telbivudine.

As of Nov 13, 2026, NDA 22011 (Tyzeka), held by Novartis, was first approved by FDA on Oct 25, 2006, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 25, 2006
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jan 28, 2013	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label
Jan 28, 2013	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 23, 2009	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 25, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tyzeka600MG · tablet;oral	Telbivudine	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 27, 2018	Supplement 22Labeling · Standard review	Approved	Letter Label Medication Guide
Mar 28, 2018	Supplement 21Labeling · Standard review	Approved	Label Letter
Dec 11, 2015	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 6, 2013	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 28, 2013	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label
Jan 28, 2013	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 23, 2011	Supplement 12Labeling · Standard review	Approved	Letter Label
May 5, 2011	Supplement 11REMS	Approved	Letter
Mar 29, 2011	Supplement 9Labeling	Approved	Letter Label
Sep 10, 2010	Supplement 6Labeling	Approved	Label Letter
Mar 4, 2010	Supplement 3Labeling · Standard review	Approved	Label Letter
May 8, 2009	Supplement 2Labeling · Standard review	Approved	Letter Label
Jan 23, 2009	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 25, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 22011
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