Arixtra

Prevents deep vein thrombosis (DVT). NDA 21345, held by Mylan Ireland Ltd. Fondaparinux Sodium.

As of Nov 15, 2026, NDA 21345 (Arixtra), held by Mylan Ireland Ltd, was first approved by FDA on Dec 7, 2001, with 17 approved supplements and 0 published complete response letters.

First approved: Dec 7, 2001
Review: Priority
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant) indicated for:

Prophylaxis of deep vein thrombosis (DVT) in adult patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery.
Treatment of DVT or acute pulmonary embolism (PE) in adult patients when administered in conjunction with warfarin sodium. ( 1.2, 1.3 )
Treatment of venous thromboembolism (VTE) in pediatric patients aged 1 year or older weighing at least 10 kg. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Dec 23, 2024	Supplement 52Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 26, 2005	Supplement 10Efficacy (new indication or use)	Approved	Letter Label
May 28, 2004	Supplement 5Efficacy (new indication or use)	Approved	Letter Label
May 28, 2004	Supplement 4Efficacy (new indication or use)	Approved	Label Letter
Jun 17, 2003	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Label Letter
Dec 7, 2001	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

4 strengths and forms


Arixtra2.5MG/0.5ML (2.5MG/0.5ML) · solution;subcutaneous	Fondaparinux Sodium	RxReference drug
Arixtra5MG/0.4ML (5MG/0.4ML) · solution;subcutaneous	Fondaparinux Sodium	RxReference drug
Arixtra7.5MG/0.6ML (7.5MG/0.6ML) · solution;subcutaneous	Fondaparinux Sodium	RxReference drug
Arixtra10MG/0.8ML (10MG/0.8ML) · solution;subcutaneous	Fondaparinux Sodium	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Dec 23, 2024	Supplement 52Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 25, 2020	Supplement 43Labeling · Standard review	Approved	Label Letter
Dec 13, 2019	Supplement 37Labeling · Standard review	Approved	Letter Label
Aug 11, 2017	Supplement 35Labeling · Standard review	Approved	Letter Label
Apr 11, 2016	Supplement 33Manufacturing · Priority review	Approved	None posted
Jul 15, 2014	Supplement 32Labeling · Standard review	Approved	Letter Label
Nov 15, 2013	Supplement 31Manufacturing · Priority review	Approved	None posted
Sep 12, 2013	Supplement 30Labeling · Standard review	Approved	Label Letter
Mar 26, 2010	Supplement 23Labeling	Approved	Label Letter
Dec 23, 2009	Supplement 25Labeling	Approved	Letter Label
Aug 14, 2009	Supplement 19Labeling · Standard review	Approved	Letter Label
Oct 17, 2008	Supplement 18Labeling · Standard review	Approved	Letter
May 26, 2005	Supplement 10Efficacy (new indication or use)	Approved	Letter Label
May 28, 2004	Supplement 5Efficacy (new indication or use)	Approved	Letter Label
May 28, 2004	Supplement 4Efficacy (new indication or use)	Approved	Label Letter
Jun 17, 2003	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Label Letter
Dec 4, 2002	Supplement 1Labeling · Standard review	Approved	Label Letter
Dec 7, 2001	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21345
Drugs@FDA: Overview at FDA
Company: Mylan Ireland Ltd

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