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

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)

• 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

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

Patient Population Altered: July 8, 2011

• FDA approves Boostrix to prevent tetanus, diphtheria, and pertussis in older people
• Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap)) FDA Approval History

Lialda (mesalamine)

Labeling Revision Approved: July 14, 2011

• Lialda (Mesalamine) Now Approved in U.S. for Maintenance of Remission of Ulcerative Colitis
• Lialda (mesalamine) FDA Approval History

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.

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

Xeomin (incobotulinumtoxinA)

New Indication Approved: July 20, 2011

• Merz Aesthetics Announces FDA Approval Of Xeomin (incobotulinumtoxinA) For The Temporary Improvement In The Appearance Of Moderate To Severe Glabellar Lines In Adult Patients
• Xeomin (incobotulinumtoxinA) FDA Approval History

Gammagard Liquid (immune globulin infusion (human))

New Dosage Form Approved: July 22, 2011

• Baxter Announces FDA Approval of Subcutaneous Route of Administration for Gammagard Liquid for Patients with Primary Immunodeficiency
• Gammagard Liquid (immune globulin infusion (human)) FDA Approval History

Welchol (colesevelam)

Labeling Revision Approved: July 18, 2011

• Once-Daily Welchol (colesevelam HCl) for Oral Suspension Receives FDA Approval To be Mixed With Fruit Juice or Diet Soft Drinks

Zyclara (imiquimod)

New Dosage Regimen: July 15, 2011

• FDA Approves Zyclara (imiquimod) Cream, 2.5% for the Treatment of Actinic Keratoses
• Zyclara (imiquimod) FDA Approval History

Orencia (abatacept)

New Formulation Approved: July 29, 2011

• U.S. Food and Drug Administration Approves Subcutaneous Formulation of Orencia (abatacept), a Proven Non-Anti-TNF Biologic for Adults with Moderate to Severe Rheumatoid Arthritis
• Orencia (abatacept) FDA Approval History

Xarelto (rivaroxaban)

New Indication Approved: November 4, 2011

• FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm
• Xarelto (rivaroxaban) FDA Approval History

Xarelto (rivaroxaban)

New Indication Approved: November 2, 2012

• FDA Expands Use of Xarelto to Treat, Reduce Recurrence of Blood Clots
• Xarelto (rivaroxaban) FDA Approval History

Brilinta (ticagrelor)

Labeling Revision Approved: March 26, 2015

• FDA Approves New Crushing Option for the Administration of Brilinta
• Brilinta (ticagrelor) FDA Approval History

Brilinta (ticagrelor)

New Indication Approved: September 3, 2015

• FDA Approves Expanded Indication for Brilinta to Include Long-Term Use in Patients with a History of Heart Attack
• Brilinta (ticagrelor) FDA Approval History

Xarelto (rivaroxaban)

New Dosage Regimen: October 27, 2017

• FDA Approves New 10 mg Dosing for Xarelto (rivaroxaban) to Reduce the Continued Risk of Venous Thromboembolism (VTE)
• Xarelto (rivaroxaban) FDA Approval History