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New Drug Approvals Archive - March 2011

March 2011

March 4

Banzel (rufinamide)

New Dosage Form Approved: March 3, 2011

Banzel (rufinamide) FDA Approval History

March 10

Benlysta (belimumab) Injection

Date of Approval: March 10, 2011
Company: Human Genome Sciences, Inc. and GlaxoSmithKline
Treatment for: Systemic Lupus Erythematosus

Benlysta (belimumab) is B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus.

Benlysta (belimumab) FDA Approval History

March 14

Gadavist (gadobutrol) Injection

Date of Approval: March 14, 2011
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Diagnostic

Gadavist (gadobutrol) is a gadolinium-based contrast agent indicated for use in diagnostic magnetic resonance imaging (MRI).

Gadavist (gadobutrol) FDA Approval History

March 16

(adenovirus type 4 and type 7 vaccine)

Date of Approval: March 16, 2011
Company: Barr Laboratories, Inc.
Treatment for: Infection Prophylaxis

Adenovirus type 4 and type 7 vaccine is an oral vaccine indicated for the prevention of febrile acute respiratory disease caused by adenovirus type 4 and type 7 in military populations.

adenovirus type 4 and type 7 vaccine FDA Approval History

March 25

Zostavax (zoster vaccine live)

Patient Population Altered: March 24, 2011

Zostavax (zoster vaccine live) FDA Approval History

March 25

Zyclara (imiquimod)

New Indication Approved: March 24, 2011

Zyclara (imiquimod) FDA Approval History

March 25

Yervoy (ipilimumab) Injection

Date of Approval: March 25, 2011
Company: Bristol-Myers Squibb
Treatment for: Melanoma - Metastatic

Yervoy (ipilimumab) is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma.

Yervoy (ipilimumab) FDA Approval History

March 29

Viramune (nevirapine)

New Formulation Approved: March 25, 2011

March 29

Sylatron (peginterferon alfa-2b)

Date of Approval: March 29, 2011
Company: Merck
Treatment for: Malignant Melanoma

Sylatron (peginterferon alfa-2b) is an alpha interferon indicated for the adjuvant treatment of melanoma.

Sylatron (peginterferon alfa-2b) FDA Approval History

January 5

Gadavist (gadobutrol)

Patient Population Altered: December 29, 2014

Gadavist (gadobutrol) FDA Approval History

October 28

Yervoy (ipilimumab)

New Indication Approved: October 28, 2015

Yervoy (ipilimumab) FDA Approval History

April 29

Gadavist (gadobutrol)

New Indication Approved: April 27, 2016

Gadavist (gadobutrol) FDA Approval History

July 21

Benlysta (belimumab)

New Formulation Approved: July 20, 2017

Benlysta (belimumab) FDA Approval History

July 24

Yervoy (ipilimumab)

Patient Population Altered: July 21, 2017

Yervoy (ipilimumab) FDA Approval History

New Drug Approvals Archive