New Drug Approvals Archive - 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
• for the prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding
• 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).

• FDA Approves Xarelto (rivaroxaban) to Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery
• Xarelto (rivaroxaban) FDA Approval History

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).

• FDA Approves Arcapta Neohaler to treat Chronic Obstructive Pulmonary Disease
• Arcapta (indacaterol) FDA Approval History

Brilinta (ticagrelor) Tablets

Date of Approval: July 20, 2011
Company: AstraZeneca
Treatment for: Acute Coronary Syndrome, Coronary Artery Disease, Cardiovascular Risk Reduction, Ischemic Stroke -- Prophylaxis

Brilinta (ticagrelor) is a P2Y₁₂ platelet inhibitor indicated:

• to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.
  Brilinta also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS.
• to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of Brilinta was established in a population with type 2 diabetes mellitus (T2DM).
• to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA).

• FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes
• Brilinta (ticagrelor) FDA Approval History