New Drug Approvals Archive

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December 2012

December 5

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.

Evarrest (fibrin sealant) FDA Approval History

December 10

Zytiga (abiraterone)

New Indication Approved: December 10, 2012

Zytiga (abiraterone) FDA Approval History

December 14

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).

Iclusig (ponatinib) FDA Approval History

December 14

(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.

raxibacumab FDA Approval History

December 14

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.

Signifor (pasireotide) FDA Approval History

December 17

Fluarix (influenza virus vaccine, inactivated)

New Formulation Approved: December 17, 2012

Fluarix (influenza virus vaccine, inactivated) FDA Approval History

December 21

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.

Adasuve (loxapine) FDA Approval History

December 21

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.

Bivigam (immune globulin intravenous) FDA Approval History

December 21

Tamiflu (oseltamivir)

Patient Population Altered: December 21, 2012

December 21

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.

Gattex (teduglutide) FDA Approval History

December 20

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.

VariZIG (varicella zoster immune globulin) FDA Approval History

December 21

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.

Juxtapid (lomitapide) FDA Approval History

December 28

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.

Eliquis (apixaban) FDA Approval History

December 28

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.

Sirturo (bedaquiline) FDA Approval History

December 31

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.

Fulyzaq (crofelemer) FDA Approval History

March 18

Eliquis (apixaban)

New Indication Approved: March 13, 2014

Eliquis (apixaban) FDA Approval History

August 21

Eliquis (apixaban)

New Indication Approved: August 21, 2014

Eliquis (apixaban) FDA Approval History

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