New Drug Approvals Archive - December 2012

Evarrest (fibrin sealant) Patch

Date of Approval: December 5, 2012
Company: Ethicon, Inc.
Treatment for: Bleeding

Evarrest (fibrin sealant patch) is indicated for use with manual compression as an adjunct to hemostasis for problematic soft tissue bleeding during surgery.

• FDA Approves Evarrest Fibrin Sealant Patch

Evarrest (fibrin sealant) FDA Approval History

Zytiga (abiraterone)

New Indication Approved: December 10, 2012

• FDA Expands Zytiga’s Use for Late-Stage Prostate Cancer

Zytiga (abiraterone) FDA Approval History

Iclusig (ponatinib) Tablets

Date of Approval: December 14, 2012
Company: Ariad Pharmaceuticals, Inc.
Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia

Iclusig (ponatinib) is a kinase inhibitor for the treatment of chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

• FDA Approves Iclusig to Treat Two Rare Types of Leukemia

Iclusig (ponatinib) FDA Approval History

(raxibacumab)

Date of Approval: December 14, 2012
Company: GlaxoSmithKline
Treatment for: Inhalation Bacillus anthracis

Raxibacumab is a human monoclonal antibody drug for the treatment of inhalational anthrax.

• FDA Approves Raxibacumab to Treat Inhalational Anthrax

raxibacumab FDA Approval History

Signifor (pasireotide) Injection

Date of Approval: December 14, 2012
Company: Novartis Pharmaceuticals Corporation
Treatment for: Cushing's Syndrome

Signifor (pasireotide) is a multireceptor targeting somatostatin analog for the treatment of patients with Cushing's disease.

• FDA Approves Signifor, a New Orphan Drug for Cushing’s Disease

Signifor (pasireotide) FDA Approval History

Fluarix (influenza virus vaccine, inactivated)

New Formulation Approved: December 17, 2012

• FDA Approves GlaxoSmithKline's Fluarix Quadrivalent - Four-strain Seasonal Influenza Vaccine for Use in the U.S.

Fluarix (influenza virus vaccine, inactivated) FDA Approval History

Adasuve (loxapine) Inhalation Powder - formerly AZ-004

Date of Approval: December 21, 2012
Company: Alexza Pharmaceuticals, Inc.
Treatment for: Agitation, Schizophrenia, Bipolar Disorder

Adasuve (loxapine) is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

• FDA Approves Adasuve (loxapine) Inhalation Powder for the Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I Disorder in Adults

Adasuve (loxapine) FDA Approval History

Bivigam (immune globulin intravenous) Infusion

Date of Approval: December 21, 2012
Company: Biotest Pharmaceuticals Corporation
Treatment for: Primary Immunodeficiency Syndrome

Bivigam is an immune globulin intravenous (human) indicated for the treatment of primary humoral immunodeficiency.

• FDA Approves Biotest's Bivigam, an Intravenous Immune Globulin (Human), 10% Liquid

Bivigam (immune globulin intravenous) FDA Approval History

Tamiflu (oseltamivir)

Patient Population Altered: December 21, 2012

• FDA Expands Tamiflu's Use to Treat Children Younger Than One Year

Gattex (teduglutide) for Injection

Date of Approval: December 21, 2012
Company: NPS Pharmaceuticals, Inc.
Treatment for: Short Bowel Syndrome

Gattex (teduglutide) is a recombinant analog of human glucagon-like peptide 2 for the treatment of adults with short bowel syndrome.

• FDA Approves Gattex to Treat Short Bowel Syndrome

Gattex (teduglutide) FDA Approval History

VariZIG (varicella zoster immune globulin) for Injection

Date of Approval: December 20, 2012
Company: Cangene Corporation
Treatment for: Varicella-Zoster

VariZIG is a varicella zoster immune globulin (human) intended to reduce the severity of chickenpox (varicella) infections in high risk individuals.

• FDA Approves Varizig for Reducing Chickenpox Symptoms

VariZIG (varicella zoster immune globulin) FDA Approval History

Juxtapid (lomitapide) Capsules

Date of Approval: December 21, 2012
Company: Aegerion Pharmaceuticals Inc.
Treatment for: Homozygous Familial Hypercholesterolemia

Juxtapid (lomitapide) is a microsomal triglyceride transfer protein inhibitor indicated for the treatment of patients with homozygous familial hypercholesterolemia.

• FDA Approves Juxtapid - New Orphan Drug for Rare Cholesterol Disorder

Juxtapid (lomitapide) FDA Approval History

Eliquis (apixaban) Tablets

Date of Approval: December 28, 2012
Company: Bristol-Myers Squibb Company and Pfizer Inc.
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery

Eliquis (apixaban) is a factor Xa inhibitor anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the prophylaxis of deep vein thrombosis (DVT) in patients who have undergone hip or knee replacement surgery.

• FDA Approves Eliquis to Reduce the Risk of Stroke, Blood Clots in Patients with Non-Valvular Atrial Fibrillation

Eliquis (apixaban) FDA Approval History

Sirturo (bedaquiline) Tablets

Date of Approval: December 28, 2012
Company: Janssen Research & Development, LLC
Treatment for: Tuberculosis -- Resistant

Sirturo (bedaquiline) is an oral diarylquinoline antimycobacterial drug indicated for the treatment of pulmonary multi-drug resistant tuberculosis.

• FDA Approves Sirturo to Treat Multi-Drug Resistant Tuberculosis

Sirturo (bedaquiline) FDA Approval History

Fulyzaq (crofelemer) Delayed-Release Tablets

Date of Approval: December 31, 2012
Company: Napo Pharmaceuticals, Inc.
Treatment for: Diarrhea

Fulyzaq (crofelemer) is a proanthocyanidin oligomer indicated to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy.

• FDA Approves Fulyzaq - First Anti-Diarrheal Drug for HIV/AIDS Patients

Fulyzaq (crofelemer) FDA Approval History

Eliquis (apixaban)

New Indication Approved: March 13, 2014

• FDA Approves Eliquis to Reduce Risk of Blood Clots Following Hip Or Knee Replacement Surgery

Eliquis (apixaban) FDA Approval History

Eliquis (apixaban)

New Indication Approved: August 21, 2014

• FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

Eliquis (apixaban) FDA Approval History