New Drug Approvals Archive - September 2013

Abraxane (paclitaxel protein-bound)

New Indication Approved: September 6, 2013

• FDA Approves Abraxane for Late-Stage Pancreatic Cancer
• Abraxane (paclitaxel protein-bound) FDA Approval History

Botox Cosmetic (onabotulinumtoxinA)

New Indication Approved: September 11, 2013

• FDA Approves Botox Cosmetic to Improve the Appearance of Crow’s Feet Lines

Stelara (ustekinumab)

New Indication Approved: September 20, 2013

• Stelara (ustekinumab) Receives FDA Approval to Treat Active Psoriatic Arthritis
• Stelara (ustekinumab) FDA Approval History

Butrans (buprenorphine)

New Dosage Regimen: September 24, 2013

• Purdue Pharma L.P. Receives FDA Approval For 15 mcg/hour Dosage Strength Of Butrans (buprenorphine) Transdermal System CIII
• Butrans (buprenorphine) FDA Approval History

Cimzia (certolizumab pegol)

New Indication Approved: September 27, 2013

• FDA Approves Cimzia for Treatment of Adult Patients with Active Psoriatic Arthritis
• Cimzia (certolizumab pegol) FDA Approval History

Perjeta (pertuzumab)

New Indication Approved: September 30, 2013

• FDA Approves Perjeta for Neoadjuvant Breast Cancer Treatment
• Perjeta (pertuzumab) FDA Approval History

Trintellix (vortioxetine) Tablets - formerly Brintellix

Date of Approval: September 30, 2013
Company: Takeda Pharmaceutical Company Limited and H. Lundbeck A/S
Treatment for: Depression

Trintellix (vortioxetine) is a multimodal antidepressant for the treatment of major depressive disorder (MDD).

• FDA Approves Brintellix to Treat Major Depressive Disorder
• Trintellix (vortioxetine) FDA Approval History

Trintellix (vortioxetine)

Labeling Revision Approved: May 2, 2016

• Brintellix (vortioxetine) Renamed Trintellix (vortioxetine) in U.S. to Avoid Name Confusion
• Trintellix (vortioxetine) FDA Approval History