Technetium Tc 99m Albumin Aggregated Kit

BLA 17881, held by Draximage. Technetium Tc-99m Albumin Aggregated Kit.

As of Nov 14, 2026, BLA 17881 (Technetium Tc 99m Albumin Aggregated Kit), held by Draximage, was first approved by FDA on Dec 30, 1987, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1987
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

DRAXIMAGE MAA, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adult patients.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Dec 30, 1987	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Technetium Tc 99m Albumin Aggregated KitN/A · injectable;injection	Technetium Tc-99m Albumin Aggregated Kit	Rx

All 14 submissions, including labeling and manufacturing supplements


Dec 1, 2023	Supplement 30Labeling · Standard review	Approved	Letter Label
Oct 20, 2017	Supplement 26Manufacturing · Standard review	Approved	Label
Jun 9, 2016	Supplement 25Manufacturing · Standard review	Approved	Letter
Mar 1, 2016	Supplement 24Manufacturing · Standard review	Approved	None posted
May 11, 2015	Supplement 23Manufacturing · Standard review	Approved	None posted
Mar 4, 2013	Supplement 22Manufacturing · Standard review	Approved	None posted
Sep 23, 2011	Supplement 16Labeling · Standard review	Approved	Label Letter
Jun 5, 2009	Supplement 10Manufacturing	Approved	Label Letter
Oct 17, 2008	Supplement 9Labeling · Standard review	Approved	Letter
Jul 23, 2002	Supplement 4Manufacturing · Standard review	Approved	Letter
Apr 2, 1999	Supplement 3Labeling · Standard review	Approved	None posted
Apr 2, 1999	Supplement 2Labeling · Standard review	Approved	None posted
Jul 17, 1989	Supplement 1Labeling	Approved	None posted
Dec 30, 1987	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: BLA 17881
Drugs@FDA: Overview at FDA
Company: Draximage

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