Ablavar

NDA 21711, held by Lantheus Medcl. Gadofosveset Trisodium.

As of Nov 14, 2026, NDA 21711 (Ablavar), held by Lantheus Medcl, was first approved by FDA on Dec 22, 2008, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 22, 2008
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 22, 2008	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter

Products

2 strengths and forms


Ablavar2440MG/10ML (244MG/ML) · solution;intravenous	Gadofosveset Trisodium	Discontinued
Ablavar3660MG/15ML (244MG/ML) · solution;intravenous	Gadofosveset Trisodium	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Aug 7, 2013	Supplement 4Labeling · Standard review	Approved	Label Letter
Dec 20, 2010	Supplement 3Labeling	Approved	Letter Label
Jan 11, 2010	Supplement 1Labeling · Standard review	Approved	Label Letter
Dec 22, 2008	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter

Identifiers

Application: NDA 21711
Drugs@FDA: Overview at FDA
Company: Lantheus Medical Imaging

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