New Drug Approvals Archive - March 2008

Aloxi (palonosetron)

New Indication Approved: February 29, 2008

• FDA Approves Aloxi (palonosetron HCl) Injection for Prevention ofPostoperative Nausea and Vomiting

Fusilev (levoleucovorin) for Injection

Date of Approval: March 7, 2008
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Methotrexate Rescue, Folic Acid Antagonist Overdose, Colorectal Cancer

Fusilev (levoleucovorin calcium) is a folate analog indicated for rescue after high-dose methotrexate therapy in osteosarcoma, diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists, and for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.

• FDA Approves New Drug Application for Levoleucovorin, Spectrum's First Proprietary Oncology Drug
• Fusilev (levoleucovorin) FDA Approval History

Artiss (fibrin sealant (human)) Topical Solution

Date of Approval: March 19, 2008
Company: Baxter Healthcare Corporation
Treatment for: Burns - External

Artiss (fibrin sealant (human)) is a slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients and for tissue adherence in facial rhytidectomy (face-lift) surgery.

• FDA Approves Artiss Medical Adhesive to Treat Burn Patients
• Artiss (fibrin sealant (human)) FDA Approval History

Treanda (bendamustine hydrochloride) Injection

Date of Approval: March 20, 2008
Company: Cephalon, Inc.
Treatment for: Chronic Lymphocytic Leukemia, non-Hodgkin's Lymphoma

Treanda (bendamustine) is a purine alkylator hybrid chemotherapy agent indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and relapsed indolent non-Hodgkin's lymphoma.

• Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic Lymphocytic Leukemia
• Treanda (bendamustine hydrochloride) FDA Approval History

Treanda (bendamustine hydrochloride)

New Indication Approved: October 31, 2008

• Cephalon Receives FDA Approval for Treanda to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma
• Treanda (bendamustine hydrochloride) FDA Approval History

Fusilev (levoleucovorin)

New Indication Approved: April 29, 2011

• FDA Approves Fusilev for Use in Patients with Colorectal Cancer
• Fusilev (levoleucovorin) FDA Approval History

Artiss (fibrin sealant (human))

New Indication Approved: August 31, 2011

• Baxter Announces FDA Approval of Artiss Fibrin Sealant for Use in Face-Lift (Facial Rhytidectomy) Procedures
• Artiss (fibrin sealant (human)) FDA Approval History