| Company* | Product | Description | Indication | Status (Date) |
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| CANCER | ||||
| Cell Pathways | Aptosyn | Exisulind | Lung cancer | An Independent Data and Safety Monitoring Board recommended resuming enrollment in the company's Phase III trial (11/12) |
| Cell Thera- | Trisenox | Arsenic trioxide injection | Chronic myeloid and acute myelocytic leukemias | Company received orphan drug designation for Trisenox (11/29) |
| ImClone | Erbitux | Monoclonal antibody targeting and blocking epidermal growth factor receptor | Irinotecan-refractory colorectal cancer | Companies completed the rolling BLA (11/1) |
| Matrix Pharm- | IntraDose | Cisplatin/epinephrine injectable gel | Recurrent or refractory head and neck cancer | Company received a non-approvable letter from the FDA (11/6) |
| NeoPharm | IL13- | Tumor-targeting product | Malignant glioma | FDA granted orphan drug status to IL13-PE38 (11/26) |
| SuperGen Inc. | ¿ | Daunorubicin | Acute leukemias | FDA granted approval (11/21) |
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| Zarix Inc.* | Thymitaq | Nolatrexed | Hepatocellular carcinoma | FDA granted orphan drug designation to Thymitaq (11/5) |
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| CARDIOVASCULAR | ||||
| Actelion Ltd. | Tracleer | Bosentan; active endothelin receptor antagonist | Pulmonary | FDA approved Tracleer (11/21) |
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| CENTRAL NERVOUS SYSTEM |
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| Amgen Inc. | Kineret | Anakinra; an interleukin-1 receptor antagonist | Rheumatoid arthritis | FDA gave Amgen clearance to market Kineret (11/14) |
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| Celgene | Focalin | Dexmethylphenidate HCl; a refined version of Ritalin | Attention deficit/ hyperactivity disorder | FDA granted marketing approval (11/15) |
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| Vernalis | Frova- | 5HT 1B/1D agonist | Migraine | FDA approved frovatriptan (11/9) |
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| MISCELLANEOUS |
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| Nexell | ¿ | Therapeutic stem cell product | Chronic granulomatous disease | FDA granted orphan drug status (11/28) |
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| Northfield | Poly- | A solution of polymerized hemoglobin that has a longer shelf life than blood | Blood substitute | FDA said it needs additional information before it can accept the BLA (11/20) |
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| Orphan | Xyrem | Sodium oxybate; oral solution | Cataplexy in narcolepsy | FDA cleared the company's contract manufacturer to produce certain classes of drugs, including Xyrem, addressing one of the issues cited in the FDA's approvable letter issued in July; the other issues were addressed in a response letter to the FDA dated in October (11/8) |
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| Notes: | ||||
| * Privately held | ||||
| Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
| LSE = London Stock Exchange; NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange | ||||
| BLA = Biologics License Application | ||||
