Company

Product

Description

Indication

Action

Amgen Inc.

Neupogen (Filgrastim)

Recombinant human granulocyte colony stimulating factor, a protein that selectively stimulates production of neutrophils

Acute myeloid leukemia (adjunct to chemotherapy)

FDA's Biological Response Modifiers Advisory Committee recommends expanded indication (7/25)

Baxter Healthcare Corp. (unit of Baxter International Inc.)

Isolex 300

Immunoselection-based cell separator

Selection and storage of stem cells prior to chemotherapy

FDA's Biologicalare Corp. Response Modifiers Committee recommended approval (7/24)

Chiron Corp.

Proleukin

Recombinant human interleukin-2

Single agent therapy for metastatic melanoma (Stage IV)

FDA Oncologic Drugs Advisory Committee recommended approval (12/19)

Eli Lilly and Co.

Evista

Selective estrogen receptor modulator (SERM)

Prevention of post-menopausal osteoporosis

FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommended approval (8-4 vote) (11/20)

Molecular Biosystems Inc. and Mallinckrodt Inc.

Albunex

Human albumin, 5%; ultrasound contrast agent

Diagnostic for use with transvaginal ultrasound to assess Fallopian tube patency

FDA's Radiological Devices Advisory Panel recommended approval of Supplemental PMA (2/24)

Molecular Biosystems Inc. and Mallinckrodt Inc.

FS 069

Second-generation ultrasound contrast agent

Diagnostic for use in echocardiography

FDA's Radiological Devices Advisory Panel recommended approval (2/24)

NaPro BioTherapeutics Inc. and Ivax Corp.

Paxene

Paclitaxel; compound extracted from needles and limb stock of ornamental yew trees

AIDS-related Kaposi's sarcoma (2nd-line therapy)

FDA's Oncologic Drugs Advisory Committee recommended approval (9/19)

Novartis AG

Neoral

Oral micro-emulsion formulation of cyclosporine

Second-line therapy for severe active rheumatoid arthritis (in patients with normal kidney function)

FDA's Arthritis Advisory Committee recommend- ed approval (2/4)

QLT PhotoTherapeutics Inc. (Canada)

Photofrin

Photosensitive drug (produces toxic oxygen compound when light activated)

To reduce obstruction and for palliation of symptoms in patients with non-small cell lung cancer (NSCLC)

FDA's Oncologic Drugs Advisory Committee voted 10-1 to approve for shrinking tumors in patients with inoperable early-stage NSCLC, but voted 9-2 against approval for palliation of symptoms in advanced NSCLC (9/18)


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