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Fragmin FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved December 22, 1994)
Brand name: Fragmin
Generic name: dalteparin sodium
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Heart Attack, Angina, Deep Vein Thrombosis, Venous Thromboembolism

Fragmin (dalteparin sodium) is a low molecular weight heparin (LMWH) indicated for:

  • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction
  • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness
  • Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the Fragmin therapy begins with the initial VTE treatment and continues for six months
  • Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month of age and older

Development timeline for Fragmin

May 16, 2019Approval FDA Approves Fragmin (dalteparin sodium) as First Anticoagulant for Venous Thromboembolism in Pediatric Patients

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.