New Drug Approvals Archive - March 2008
New Indication Approved: February 29, 2008
Fusilev (levoleucovorin) for Injection - formerly Isovorin
Date of Approval: March 7, 2008
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.
Artiss (fibrin sealant (human)) Topical Solution
Date of Approval: March 19, 2008
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.
Treanda (bendamustine hydrochloride) Injection
Date of Approval: March 20, 2008
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)
New Indication Approved: October 31, 2008
New Indication Approved: April 29, 2011
Artiss (fibrin sealant (human))
New Indication Approved: August 31, 2011