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

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

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

Lialda (mesalamine)

Labeling Revision Approved: July 14, 2011

Lialda (Mesalamine) Now Approved in U.S. for Maintenance of Remission of Ulcerative Colitis

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

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

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

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

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

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)

New Indication Approved: November 2, 2012

FDA Expands Use of Xarelto to Treat, Reduce Recurrence of Blood Clots

Brilinta (ticagrelor)

Labeling Revision Approved: March 26, 2015

FDA Approves New Crushing Option for the Administration of Brilinta

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

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)