New Drug Approvals Archive

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March 2008

March 3

Aloxi (palonosetron)

New Indication Approved: February 29, 2008

March 7

Fusilev (levoleucovorin) for Injection - formerly Isovorin

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.

Fusilev (levoleucovorin) FDA Approval History

March 19

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.

Artiss (fibrin sealant (human)) FDA Approval History

March 20

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.

Treanda (bendamustine hydrochloride) FDA Approval History

November 3

Treanda (bendamustine hydrochloride)

New Indication Approved: October 31, 2008

Treanda (bendamustine hydrochloride) FDA Approval History

May 2

Fusilev (levoleucovorin)

New Indication Approved: April 29, 2011

Fusilev (levoleucovorin) FDA Approval History

August 31

Artiss (fibrin sealant (human))

New Indication Approved: August 31, 2011

Artiss (fibrin sealant (human)) FDA Approval History

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