FONDAPARINUX SODIUM

Post-LOE

fondaparinux sodium

Dr. Reddy's Laboratories

ANDASUBCUTANEOUSSOLUTION

Approved

Nov 2018

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

FONDAPARINUX SODIUM (fondaparinux sodium) by Dr. Reddy's Laboratories is (atiii)-mediated selective inhibition of factor xa. Approved for deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): in patients undergoing hip fracture surgery, including extended prophylaxis and 2 more indications. First approved in 2018.

Drug data last refreshed 21h ago

Mechanism of Action

(ATIII)-mediated selective inhibition of Factor Xa. By selectively binding to ATIII, fondaparinux sodium potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII. Neutralization of Factor Xa interrupts the blood coagulation cascade and thus inhibits thrombin formation and…

Indications (5)

deep vein thrombosis (DVT)which may lead to pulmonary embolism (PE): in patients undergoing hip fracture surgery

Worked on FONDAPARINUX SODIUM at Dr. Reddy's Laboratories? Share your interview experience or compensation data (+7 days Pro)

Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (8)

NCT00911157Phase 3Completed

The Treatment of Acute Deep Vein Thrombosis (DVT) of GSK576428 (Fondaparinux Sodium) in Japanese Patients

Started Jun 2008

39 enrolled

Thrombosis, Venous

NCT00981409Phase 3Completed

The Treatment of Acute Pulmonary Thromboembolism (PE) of GSK576428 (Fondaparinux Sodium) in Japanese Patients

Started Jul 2007

41 enrolled

Embolism, Pulmonary

NCT00539942Phase 3Terminated

Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy

Started Apr 2007

7 enrolled

Venous Thrombosis

NCT00436787Phase 2Completed

Investigation Into the Therapeutic Dosage of Fondaparinux Sodium, a Medication Used to Prevent Blood Clots in Morbidly Obese Volunteers

Started Feb 2007

21 enrolled

Venous ThrombosisPulmonary Embolism

NCT00333021Phase 3Completed

Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese Patients

Started May 2006

127 enrolled

Venous Thromboembolism