New Drug Approvals Archive

Humira (adalimumab)

New Indication Approved: October 3, 2005

• Humira Receives FDA Approval for Psoriatic Arthritis

Flexbumin (albumin human) Solution

Date of Approval: October 17, 2005
Company: Baxter Healthcare Corporation
Treatment for: Plasma Volume Expansion

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.

• Flexbumin Baxter Healthcare Corporation - Treatment for Plasma Volume Expansion

Flexbumin (albumin human) FDA Approval History

Arranon (nelarabine) Injection

Date of Approval: October 28, 2005
Company: GlaxoSmithKline
Treatment for: Acute Lymphoblastic Leukemia, Lymphoma

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.

• Arranon GlaxoSmithKline - Treatment for Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

Arranon (nelarabine) FDA Approval History

Soltamox (tamoxifen) Oral Solution

Date of Approval: October 29, 2005
Company: Savient Pharmaceuticals, Inc.
Treatment for: Breast Cancer

Soltamox is an oral liquid formulation of tamoxifen indicated for the treatment of breast cancer.

• Soltamox Savient Pharmaceuticals, Inc. - Treatment for Breast Cancer

Soltamox (tamoxifen) FDA Approval History