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New Drug Approvals Archive - September 2007

September 2007

September 4

Aloxi (palonosetron)

New Dosage Regimen: August 30, 2007

September 6

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 (dexrazoxane) FDA Approval History

September 21

Norditropin (somatropin [rDNA origin])

New Indication Approved: September 20, 2007

September 26

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 (amlodipine and olmesartan) FDA Approval History

September 28

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 of persons ages 18 years and older against influenza disease.

Afluria (influenza virus vaccine) FDA Approval History

May 13

Azor (amlodipine and olmesartan)

New Indication Approved: May 11, 2009

Azor (amlodipine and olmesartan) FDA Approval History

August 29

Afluria (influenza virus vaccine)

New Formulation Approved: August 29, 2016

Afluria (influenza virus vaccine) FDA Approval History

New Drug Approvals Archive