Company |
Product |
Description |
Indication |
Status (Date) |
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CANCER | ||||
Atrix Labora- |
Eligard (formerly Leuprogel One-month Depot) |
One-month treatment; leuprolide acetate that is injected subcutaneously using Atrix's Atrigel drug delivery system |
Advanced prostate cancer |
FDA approved Eligard 7.5 mg (1/24) |
Corixa Corp. |
Bexxar |
Radioimmunotherapy antibody conjugated to iodine-131 |
Non-Hodgkin's lymphoma |
FDA's Oncologic Drugs Advisory Committee is delaying a hearing on the drug because it needs more time to go through the material (1/10) |
IDEC Pharma- |
Zevalin |
Radiolabeled mouse monoclonal antibody targeted against the CD20 antigen; ibritumomab tiuxetan |
Non-Hodgkin's lymphoma |
Company's launch of the product is delayed due to manufacturing concerns of the FDA (1/8) |
CARDIOVASCULAR |
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Hemosol Inc. |
Hemolink |
Oxygen therapeutic |
Cardiac bypass grafting surgery |
FDA gave Hemosol notice to proceed with a clinical trial of Hemolink in "re-do" cardiac by-pass grafting surgery (1/31) |
InterMune |
Actimmune |
Interferon gamma 1b injection |
Idiopathic pulmonary fibrosis |
FDA granted fast-track designation for Actimmune (1/7); a Data Safety Monitoring Board recommended the company continue the 330-patient Phase III trial (1/17) |
CENTRAL NERVOUS SYSTEM |
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Chiron Corp. |
Betaseron |
Interferon beta-1b |
Multiple sclerosis |
FDA approved a new room-temperature formulation of Betaseron for subcutaneous injection (1/15) |
INFECTION |
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Aviron Inc. |
FluMist |
Intranasal influenza |
Influenza |
Company submitted to the FDA a formal reply to the complete response letter the FDA sent Aviron on Aug. 31, related to its BLA for FluMist (1/8) |
INFLAMMATION AND PAIN |
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Immunex |
Enbrel |
Tumor necrosis factor-inhibiting drug; etanercept |
Psoriatic arthritis |
FDA approved Enbrel for this additional indication (1/16) |
MISCELLANEOUS |
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ISTA Pharma- |
Vitrase |
Injectable enzyme; hyaluronidase |
Severe vitreous hemorrhage |
Company submitted the initial section of the NDA to the FDA (1/4) |
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Sepracor |
Xopenex |
Levalbuterol HCl |
Treatment or prevention of bronchospasm in children with reversible obstructive airway disease |
FDA pproved Xopenex in children ages 6 to 11; it was previously approved for patients ages 12 and older (1/31) |
Transkaryotic Therapies Inc. (TKTX) |
Iduronate-2- |
Enzyme replacement therapy |
Hunter syndrome |
The product was given orphan drug status in both Europe and the U.S. (1/3) |
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Notes: | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
TSE = Toronto Stock Exchange | ||||
BLA = Biologics License Application; NDA = New Drug Application | ||||
