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New Drug Approvals Archive - September 2012

September 2012

Bosulif (bosutinib) Tablets

Date of Approval: September 4, 2012
Company: Pfizer Inc.
Treatment for: Chronic Myelogenous Leukemia

Bosulif (bosutinib) is a kinase inhibitor indicated for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia (CML).

Aubagio (teriflunomide) Tablets

Date of Approval: September 12, 2012
Company: Sanofi
Treatment for: Multiple Sclerosis

Aubagio (teriflunomide) is an oral pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Stivarga (regorafenib) Tablets

Date of Approval: September 27, 2012
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Colorectal Cancer, Gastrointestinal Stromal Tumor, Hepatocellular Carcinoma

Stivarga (regorafenib) is an oral multi-kinase inhibitor for the treatment of patients with metastatic colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma.

Humira (adalimumab)

New Indication Approved: September 28, 2012

Quillivant XR (methylphenidate) for Extended-Release Oral Suspension

Date of Approval: September 27, 2012
Company: NextWave Pharmaceuticals, Inc.
Treatment for: Attention Deficit Disorder

Quillivant XR (methylphenidate) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

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