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New Drug Approvals Archive - September 2007

September 2007

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.

Read more: Totect (dexrazoxane) FDA Approval History

Norditropin (somatropin [rDNA origin])

New Indication Approved: September 20, 2007

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.

Read more: 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.

Read more: Afluria (influenza virus vaccine) FDA Approval History

New Drug Approvals Archive