New Drug Approvals Archive

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

Eliquis (apixaban) is a factor Xa inhibitor anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

• 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: Salix Pharmaceuticals, Ltd.
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