Quadramet

NDA 20570, held by Lantheus Medical. Samarium Sm-153 Lexidronam Pentasodium.

As of Nov 13, 2026, NDA 20570 (Quadramet), held by Lantheus Medical, was first approved by FDA on Mar 28, 1997, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 28, 1997
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 28, 1997	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Quadramet50mCi/ML · injectable;injection	Samarium Sm-153 Lexidronam Pentasodium	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Sep 21, 2017	Supplement 8Labeling · Standard review	Approved	Letter Label
May 13, 2009	Supplement 4Manufacturing	Approved	Letter
Apr 12, 1999	Supplement 2Labeling · Standard review	Approved	None posted
Jan 29, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 28, 1997	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20570
Drugs@FDA: Overview at FDA
Company: Lantheus

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