Caprelsa

Treats symptomatic or progressive medullary thyroid cancer. NDA 22405, held by Genzyme Corp. Vandetanib.

As of Nov 14, 2026, NDA 22405 (Caprelsa), held by Genzyme Corp, was first approved by FDA on Apr 6, 2011, with 18 approved supplements and 0 published complete response letters.

First approved: Apr 6, 2011
Review: Priority
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Mar 7, 2024	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Oct 12, 2018	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 6, 2011	Original applicationNew molecular entity · Priority review	Approved	Other Review Summary Review Label

Products

2 strengths and forms


Caprelsa100MG · tablet;oral	Vandetanib	RxReference drug
Caprelsa300MG · tablet;oral	Vandetanib	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Jan 27, 2026	Supplement 26Labeling · Standard review	Approved	Letter Label
Sep 23, 2025	Supplement 25REMS	Approved	Letter
Jun 26, 2025	Supplement 24REMS	Approved	Letter
May 14, 2025	Supplement 23Labeling · Standard review	Approved	Letter Label Medication Guide
Mar 7, 2024	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Apr 13, 2023	Supplement 21REMS	Approved	Letter
Mar 28, 2022	Supplement 19Labeling · Standard review	Approved	Label Letter
Jun 15, 2020	Supplement 17Labeling · Standard review	Approved	Letter Label
Jun 5, 2020	Supplement 16Labeling · Standard review	Approved	Letter Label
Oct 12, 2018	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 16, 2017	Supplement 9REMS	Approved	Letter
Feb 24, 2017	Supplement 11Labeling · Standard review	Approved	None posted
Jul 28, 2016	Supplement 10Labeling · Standard review	Approved	Label Letter
Mar 31, 2014	Supplement 7Labeling · Standard review	Approved	Letter Label
Nov 27, 2013	Supplement 5Labeling · Standard review	Approved	Letter
Jul 3, 2013	Supplement 4Labeling · Standard review	Approved	Letter Label
Oct 9, 2012	Supplement 3Labeling · Standard review	Approved	Label Letter
Jun 22, 2011	Supplement 1Labeling	Approved	Letter Label
Apr 6, 2011	Original applicationNew molecular entity · Priority review	Approved	Other Review Summary Review Label

Identifiers

Application: NDA 22405
Drugs@FDA: Overview at FDA
Company: Genzyme

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