New Drug Approvals Archive

Levemir (insulin detemir )

Labeling Revision Approved: March 29, 2012

• FDA Approves Levemir Pregnancy Category Change for Women with Diabetes

Levemir (insulin detemir ) FDA Approval History

Neupro (rotigotine)

New Indication Approved: April 2, 2012

• Neupro Approved by U.S. FDA for Parkinson's Disease and Restless Legs Syndrome

Neupro (rotigotine) FDA Approval History

Amyvid (florbetapir F 18) Injection

Date of Approval: April 6, 2012
Company: Eli Lilly and Company and Avid Radiopharmaceuticals, Inc.
Treatment for: Diagnostic

Amyvid (florbetapir F 18) is a radioactive diagnostic agent used for brain imaging of beta-amyloid plaques in patients who are being evaluated for Alzheimer's Disease and other causes of cognitive decline.

• FDA Approves Amyvid (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline

Amyvid (florbetapir F 18) FDA Approval History

Victoza (liraglutide)

Labeling Revision Approved: April 6, 2012

• Victoza Label Updated to Include Data Showing Superior Efficacy When Compared to Januvia

Victoza (liraglutide) FDA Approval History

Afinitor (everolimus)

Labeling Revision Approved: April 26, 2012

• Novartis drug Afinitor approved by FDA as first medication to treat patients with non-cancerous kidney tumors associated with TSC

Afinitor (everolimus) FDA Approval History

Votrient (pazopanib)

New Indication Approved: April 26, 2012

• FDA Approves Votrient for Advanced Soft Tissue Sarcoma

Votrient (pazopanib) FDA Approval History

Stendra (avanafil) Tablets

Date of Approval: April 27, 2012
Company: Vivus, Inc.
Treatment for: Erectile Dysfunction

Stendra (avanafil) is a phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED).

• FDA Approves Stendra for Erectile Dysfunction

Stendra (avanafil) FDA Approval History

Levaquin (levofloxacin)

New Indication Approved: April 27, 2012

• FDA Approves Levaquin as an Antibacterial Treatment for Plague