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New Drug Approvals Archive - March 2011

March 2011

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.

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).

(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.

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.

Viramune (nevirapine)

New Formulation Approved: March 25, 2011

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.

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