New Drug Approvals Archive

New Drug Approvals: October 2005

October 4
Humira (adalimumab)

New Indication Approved: October 3, 2005

Humira Receives FDA Approval for Psoriatic Arthritis
 
October 17
Flexbumin (Albumin (Human)) Solution

Date of Approval: October 17, 2005

Company: Baxter Healthcare Corporation

Treatment for Plasma Volume Expansion

Flexbumin 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
 
October 28
Arranon (nelarabine) Injection

Date of Approval: October 28, 2005

Company: GlaxoSmithKline

Treatment for Acute Lymphoblastic Leukemia, Lymphoma

Arranon 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
 
October 29
Soltamox (tamoxifen) Oral Solution

Company: Savient Pharmaceuticals, Inc.

Treatment for Breast Cancer

Soltamox Savient Pharmaceuticals, Inc. - Treatment for Breast Cancer
 

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