FDA Approved: DABIGATRAN ETEXILATE — Original Application (Mylan Pharmaceuticals Inc.)

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Summary

FDA approved Mylan's original Abbreviated New Drug Application for dabigatran etexilate, enabling a generic version of this anticoagulant to be marketed.

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Diseases / indications

• Deep Vein Thrombosis
• Nonvalvular Atrial Fibrillation
• Pulmonary Embolism

Drugs mentioned

• Dabigatran etexilate (Dabigatran etexilate)

Snippet

ORIG AP for DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)