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New Drug Approvals Archive

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September 2008

September 3

Omnitrope (somatropin (rDNA origin))

New Formulation Approved: August 25, 2008

Omnitrope (somatropin (rDNA origin)) FDA Approval History

September 15

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant)

New Indication Approved: September 12, 2008

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) FDA Approval History

September 12

Sancuso (granisetron) Transdermal Patch

Date of Approval: September 12, 2008
Company: ProStrakan Group plc
Treatment for: Nausea/Vomiting -- Chemotherapy Induced

Sancuso (granisetron transdermal system) is an anti-emetic transdermal delivery system indicated for the control of nausea and vomiting in patients receiving moderately and/or highly nausea-inducing chemotherapy.

Sancuso (granisetron) FDA Approval History

September 15

Keppra (levetiracetam)

New Dosage Form Approved: September 12, 2008

September 15

Gamunex (immune globulin intravenous (human))

New Indication Approved: September 12, 2008

September 19

AdreView (iobenguane I 123) Injection

Date of Approval: September 19, 2008
Company: GE Healthcare
Treatment for: Diagnostic

AdreView is a diagnostic radiopharmaceutical agent indicated for use in the detection of rare neuroendocrine tumors in children and adults.

AdreView (iobenguane I 123) FDA Approval History

September 23

Nasacort (triamcinolone acetonide)

Patient Population Altered: September 19, 2008

September 24

ProAir HFA (albuterol sulfate)

Patient Population Altered: September 16, 2008

ProAir HFA (albuterol sulfate) FDA Approval History

September 29

Alimta (pemetrexed)

New Indication Approved: September 26, 2008

Alimta (pemetrexed) FDA Approval History

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