New Drug Approvals Archive

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July 2011

July 1

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

Xarelto (rivaroxaban) is a factor Xa inhibitor indicated for the prophylaxis of deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery, to reduce the risk of stroke in people who have abnormal heart rhythm (non-valvular atrial fibrillation) and to treat and reduce the risk of deep vein thrombosis (DVT) or pulmonary embolism (PE)

Xarelto (rivaroxaban) FDA Approval History

July 1

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).

Arcapta (indacaterol) FDA Approval History

July 11

Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap))

Patient Population Altered: July 8, 2011

Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap)) FDA Approval History

July 18

Lialda (mesalamine)

Labeling Revision Approved: July 14, 2011

Lialda (mesalamine) FDA Approval History

July 20

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.

Brilinta (ticagrelor) FDA Approval History

July 21

Xeomin (incobotulinumtoxinA)

New Indication Approved: July 20, 2011

Xeomin (incobotulinumtoxinA) FDA Approval History

July 25

Gammagard Liquid (immune globulin infusion (human))

New Dosage Form Approved: July 22, 2011

Gammagard Liquid (immune globulin infusion (human)) FDA Approval History

July 25

Welchol (colesevelam)

Labeling Revision Approved: July 18, 2011

July 29

Zyclara (imiquimod)

New Dosage Regimen: July 15, 2011

Zyclara (imiquimod) FDA Approval History

July 31

Orencia (abatacept)

New Formulation Approved: July 29, 2011

Orencia (abatacept) FDA Approval History

November 4

Xarelto (rivaroxaban)

New Indication Approved: November 4, 2011

Xarelto (rivaroxaban) FDA Approval History

November 2

Xarelto (rivaroxaban)

New Indication Approved: November 2, 2012

Xarelto (rivaroxaban) FDA Approval History

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