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New Drug Approvals Archive

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September 2012

September 4

Exelon (rivastigmine)

New Formulation Approved: August 31, 2012

September 4

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).

Bosulif (bosutinib) FDA Approval History

September 12

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.

Aubagio (teriflunomide) FDA Approval History

September 21

Prolia (denosumab)

New Indication Approved: September 21, 2012

Prolia (denosumab) FDA Approval History

September 27

Stivarga (regorafenib) Tablets

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

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

Stivarga (regorafenib) FDA Approval History

September 28

Humira (adalimumab)

New Indication Approved: September 28, 2012

September 27

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).

Quillivant XR (methylphenidate) FDA Approval History

February 25

Stivarga (regorafenib)

New Indication Approved: February 25, 2013

Stivarga (regorafenib) FDA Approval History

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