New Drug Approvals Archive - October 2005
New Indication Approved: October 3, 2005
Flexbumin (albumin human) Solution
Date of Approval: October 17, 2005
Flexbumin (albumin human) is the first human serum albumin preparation packaged in a flexible container (previously packaged in glass bottles). Flexbumin is indicated in hypovolemia, hypoalbuminemia due to inadequate reproduction, excessive catabolism, hemorrhage, major surgery or burns, and for use during cardiopulmonary bypass surgery.
Arranon (nelarabine) Injection
Date of Approval: October 28, 2005
Arranon (nelarabine) is a chemotherapy agent indicated for the treatment of adults and children with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Soltamox (tamoxifen) Oral Solution
Date of Approval: October 29, 2005
Soltamox is an oral liquid formulation of tamoxifen indicated for the treatment of breast cancer.