Nexavar

Treats • Unresectable hepatocellular carcinoma. NDA 21923, held by Bayer Hlthcare. Sorafenib Tosylate.

As of Nov 14, 2026, NDA 21923 (Nexavar), held by Bayer Hlthcare, was first approved by FDA on Dec 1, 2005, with 22 approved supplements and 0 published complete response letters.

First approved: Dec 1, 2005
Review: Priority
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NEXAVAR is a kinase inhibitor indicated for the treatment of

Unresectable hepatocellular carcinoma
Advanced renal cell carcinoma
Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment 1.1 Hepatocellular Carcinoma NEXAVAR is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.2 Renal Cell Carcinoma NEXAVAR is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Dec 22, 2017	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 22, 2013	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 16, 2007	Supplement 7Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 16, 2007	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 16, 2007	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 16, 2007	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 1, 2005	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
NexavarEQ 200MG BASE · tablet;oral	Sorafenib Tosylate	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Aug 28, 2023	Supplement 26Manufacturing	Approved	Letter Label
May 20, 2021	Supplement 25Labeling · Standard review	Approved	Label Letter
Jul 9, 2020	Supplement 24Labeling · Standard review	Approved	Label Letter
Jun 19, 2020	Supplement 22Labeling · Standard review	Approved	Label Letter
Apr 2, 2020	Supplement 23Labeling · Standard review	Approved	Label Letter
Dec 6, 2018	Supplement 20Labeling · Standard review	Approved	Label Letter
Dec 6, 2018	Supplement 19Labeling · Standard review	Approved	Label Letter
Dec 22, 2017	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 2, 2014	Supplement 17Manufacturing · Priority review	Approved	None posted
Nov 22, 2013	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 30, 2013	Supplement 15Labeling · Standard review	Approved	Label Letter
Jun 11, 2013	Supplement 14Labeling · Standard review	Approved	Label Letter
Aug 24, 2012	Supplement 13Labeling · Standard review	Approved	Letter
Oct 14, 2011	Supplement 12Labeling · Standard review	Approved	Label Letter
Mar 22, 2011	Supplement 11Labeling · Standard review	Approved	Label Letter
Oct 26, 2010	Supplement 9Labeling	Approved	Letter Label
Oct 26, 2010	Supplement 8Labeling · Standard review	Approved	Letter Label
Nov 16, 2007	Supplement 7Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 16, 2007	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 16, 2007	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 16, 2007	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 5, 2007	Supplement 3Labeling · Standard review	Approved	Letter
Dec 1, 2005	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21923
Drugs@FDA: Overview at FDA
Company: Bayer Healthcare

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