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New Drug Approvals Archive - December 2012

See also: New Indications and Dosage Forms for December 2012

December 2012

Fluarix Quadrivalent (influenza virus vaccine, inactivated) Injection

Date of Approval: December 14, 2012
Company: GlaxoSmithKline
Treatment for: Influenza Prophylaxis

Fluarix Quadrivalent is an inactivated influenza virus vaccine indicated for the prevention of influenza disease in people aged 6 months and older.

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.

Iclusig (ponatinib) Tablets

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

Iclusig (ponatinib) is a kinase inhibitor indicated for the treatment of adult patients with:
  • Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.
  • Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated.
  • T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.

(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.

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.

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.

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.

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 short bowel syndrome in adults and pediatric patients one year of age and older.

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.

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.

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.

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.

Mytesi (crofelemer) Delayed-Release Tablets - formerly Fulyzaq

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

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

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