New Drug Approvals Archive - September 2012

Exelon (rivastigmine)

New Formulation Approved: August 31, 2012

• Higher Dose of Novartis Drug Exelon Patch Approved By FDA for Patients With Mild to Moderate Alzheimer's Disease

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).

• FDA Approves Bosulif for Chronic Myelogenous Leukemia
• Bosulif (bosutinib) FDA Approval History

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.

• FDA Approves New Multiple Sclerosis Treatment Aubagio
• Aubagio (teriflunomide) FDA Approval History

Prolia (denosumab)

New Indication Approved: September 21, 2012

• FDA Approves New Indication For Prolia (Denosumab) For The Treatment Of Bone Loss In Men With Osteoporosis At High Risk For Fracture
• Prolia (denosumab) FDA Approval History

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.

• FDA Approves Stivarga for Advanced Colorectal Cancer
• Stivarga (regorafenib) FDA Approval History

Humira (adalimumab)

New Indication Approved: September 28, 2012

• FDA Approves Humira to Treat Ulcerative Colitis

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).

• NextWave Pharmaceuticals Receives FDA Approval of Quillivant XR for Once-Daily Treatment of ADHD
• Quillivant XR (methylphenidate) FDA Approval History

Stivarga (regorafenib)

New Indication Approved: February 25, 2013

• FDA Approves Stivarga for Advanced Gastrointestinal Stromal Tumors
• Stivarga (regorafenib) FDA Approval History

Stivarga (regorafenib)

New Indication Approved: April 27, 2017

• FDA Expands Approved Use of Stivarga (regorafenib) to Treat Hepatocellular Carcinoma
• Stivarga (regorafenib) FDA Approval History

Bosulif (bosutinib)

New Indication Approved: December 19, 2017

• FDA Approves Pfizer’s Bosulif (bosutinib) for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia (CML)
• Bosulif (bosutinib) FDA Approval History