New Drug Approvals Archive - March 2011

Banzel (rufinamide)

New Dosage Form Approved: March 3, 2011

• FDA Approves Banzel (rufinamide) Oral Suspension, 40 mg/mL

Banzel (rufinamide) FDA Approval History

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.

• FDA Approves Benlysta to Treat Lupus

Benlysta (belimumab) FDA Approval History

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).

• U.S. FDA Approves Bayer's Gadavist (gadobutrol) Injection for MRI of the Central Nervous System

Gadavist (gadobutrol) FDA Approval History

(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.

• FDA Approves the New Adenovirus Vaccine

adenovirus type 4 and type 7 vaccine FDA Approval History

Zostavax (zoster vaccine live)

Patient Population Altered: March 24, 2011

• FDA Expands Indication for Zostavax, Merck's Shingles Vaccine, to Include Adults Ages 50 to 59

Zostavax (zoster vaccine live) FDA Approval History

Zyclara (imiquimod)

New Indication Approved: March 24, 2011

• FDA Approves Zyclara (imiquimod) Cream, 3.75% for the Treatment of External Genital Warts

Zyclara (imiquimod) FDA Approval History

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.

• FDA Approves Yervoy for Late-Stage Melanoma

Yervoy (ipilimumab) FDA Approval History

Viramune (nevirapine)

New Formulation Approved: March 25, 2011

• FDA Approves Viramune XR (nevirapine) 400 mg extended release tablet

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.

• FDA Approves Merck's Sylatron (peginterferon alfa-2b) for Injection, a New Adjuvant Treatment for Melanoma with Microscopic or Gross Nodal Involvement

Sylatron (peginterferon alfa-2b) FDA Approval History

Gadavist (gadobutrol)

Patient Population Altered: December 29, 2014

• FDA Approves Gadavist (gadobutrol) as the First MRI Contrast Agent for Patients Less Than 2 Years

Gadavist (gadobutrol) FDA Approval History

Yervoy (ipilimumab)

New Indication Approved: October 28, 2015

• FDA Approves Yervoy to Reduce the Risk of Melanoma Returning after Surgery

Yervoy (ipilimumab) FDA Approval History

Gadavist (gadobutrol)

New Indication Approved: April 27, 2016

• FDA Approves Bayer's Gadavist (gadobutrol) Injection for use with Magnetic Resonance Angiography of Supra-Aortic Arteries

Gadavist (gadobutrol) FDA Approval History