New Drug Approvals Archive - September 2007

Aloxi (palonosetron)

New Dosage Regimen: August 30, 2007

• MGI Pharma and Helsinn Announce Aloxi sNDA Approval Allowing forRepeated Dosing for Cancer Patients Receiving Multiple DayChemotherapy Regimens

Totect (dexrazoxane)

Date of Approval: September 6, 2007
Company: TopoTarget A/S
Treatment for: Anthracycline Extravasation

Totect (dexrazoxane) is a topoisomerase inhibitor used as a detoxifying agent for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.

• Totect Approved in the United States
• Totect (dexrazoxane) FDA Approval History

Norditropin (somatropin [rDNA origin])

New Indication Approved: September 20, 2007

• Norditropin Approved for Treatment of Children with Short StatureAssociated with Turner Syndrome

Azor (amlodipine and olmesartan) Tablets - formerly amlodipine and olmesartan

Date of Approval: September 26, 2007
Company: Daiichi Sankyo, Inc.
Treatment for: Hypertension

Azor is a fixed-dose combination of two antihypertensives, the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil. Azor is indicated for the treatment of hypertension.

• Azor Receives FDA Approval for Treatment of High Blood Pressure
• Azor (amlodipine and olmesartan) FDA Approval History

Afluria (influenza virus vaccine) Injection

Date of Approval: September 28, 2007
Company: CSL Biotherapies
Treatment for: Influenza Prophylaxis

Afluria (influenza virus vaccine) is an inactivated influenza virus vaccine, indicated for active immunization against influenza disease.

• CSL Biotherapies Announces FDA Marketing Approval of Afluria
• Afluria (influenza virus vaccine) FDA Approval History

Azor (amlodipine and olmesartan)

New Indication Approved: May 11, 2009

• Azor Receives FDA Approval as First-Line Treatment for High Blood Pressure
• Azor (amlodipine and olmesartan) FDA Approval History

Afluria (influenza virus vaccine)

New Formulation Approved: August 29, 2016

• Seqirus Receives FDA Approval for Afluria Quadrivalent (Influenza Vaccine) for People 18 Years of Age and Older
• Afluria (influenza virus vaccine) FDA Approval History

Afluria (influenza virus vaccine)

Patient Population Altered: August 31, 2017

• Seqirus Receives FDA Approval of Afluria Quadrivalent (Influenza Vaccine) for People Five Years of Age and Older in the U.S.
• Afluria (influenza virus vaccine) FDA Approval History