New Drug Approvals Archive - September 2012
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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 |
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 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. 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 |
New Indication Approved: February 25, 2013
Stivarga (regorafenib) FDA Approval History |
| April 27 |
New Indication Approved: April 27, 2017
Stivarga (regorafenib) FDA Approval History |
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