New Drug Approvals Archive

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
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.

• 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