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New Drug Approvals Archive - July 2011

See also: New Indications and Dosage Forms for July 2011

July 2011

Xarelto (rivaroxaban) Tablets

Date of Approval: July 1, 2011
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery, Prevention of Thromboembolism in Atrial Fibrillation, Coronary Artery Disease, Peripheral Arterial Disease, Deep Vein Thrombosis, Pulmonary Embolism

Xarelto (rivaroxaban) is a factor Xa inhibitor indicated:

  • to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
  • for the treatment of deep vein thrombosis (DVT)
  • for the treatment of pulmonary embolism (PE)
  • for the reduction in the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months
  • for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery
  • in combination with aspirin, to reduce the risk of major cardiovascular events (cardiovascular (CV) death, myocardial infarction (MI) and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD)

Arcapta (indacaterol) Neohaler - formerly QAB149

Date of Approval: July 1, 2011
Company: Novartis Pharmaceuticals Corp.
Treatment for: Chronic Obstructive Pulmonary Disease

Arcapta (indacaterol inhalation powder) is a long-acting beta2-agonist (LABA) for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Brilinta (ticagrelor) Tablets

Date of Approval: July 20, 2011
Company: AstraZeneca
Treatment for: Acute Coronary Syndrome

Brilinta (ticagrelor) is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome.

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