New Drug Approvals Archive

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October 2005

October 4

Humira (adalimumab)

New Indication Approved: October 3, 2005

October 17

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 (albumin human) FDA Approval History

October 28

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 (nelarabine) FDA Approval History

October 29

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 (tamoxifen) FDA Approval History

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