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, Renal Cell Carcinoma, Colorectal Cancer

Yervoy (ipilimumab) is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma. Yervoy is also used in combination with Opdivo (nivolumab) for the treatment of advanced renal cell carcinoma, and microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer.

• 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

Benlysta (belimumab)

New Formulation Approved: July 20, 2017

• GSK Receives FDA Approval for a New Self-Injectable Formulation of Benlysta (belimumab) for Systemic Lupus Erythematosus
• Benlysta (belimumab) FDA Approval History

Yervoy (ipilimumab)

Patient Population Altered: July 21, 2017

• FDA Expands Approval of Yervoy (ipilimumab) to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma
• Yervoy (ipilimumab) FDA Approval History