New Drug Approvals Archive

Omnitrope (somatropin (rDNA origin))

New Formulation Approved: August 25, 2008

• Sandoz Receives FDA Approval for Omnitrope Pen 10 With Liquid Cartridge

Omnitrope (somatropin (rDNA origin)) FDA Approval History

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

New Indication Approved: September 12, 2008

• FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers

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

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.

• FDA Approves Sancuso, the First and Only Patch for Preventing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy

Sancuso (granisetron) FDA Approval History

Keppra (levetiracetam)

New Dosage Form Approved: September 12, 2008

• Keppra XR Approved in the U.S.

Gamunex (immune globulin intravenous (human))

New Indication Approved: September 12, 2008

• FDA Grants Approval to Talecris Biotherapeutics for Gamunex as a Treatment for Neurological Disorder CIDP in the United States

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.

• FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection) Diagnostic Agent for Detecting Neuroendocrine Tumors in Children, Adults

AdreView (iobenguane I 123) FDA Approval History

Nasacort (triamcinolone acetonide)

Patient Population Altered: September 19, 2008

• FDA Approves Nasacort AQ Nasal Spray for Children Aged 2-5 years old

ProAir HFA (albuterol sulfate)

Patient Population Altered: September 16, 2008

• Teva's ProAir HFA, the Market Leading Albuterol Inhaler, Receives New Pediatric Indication

ProAir HFA (albuterol sulfate) FDA Approval History

Alimta (pemetrexed)

New Indication Approved: September 26, 2008

• FDA Grants Lilly's Alimta (Pemetrexed for Injection) Third U.S. Approval

Alimta (pemetrexed) FDA Approval History