Company | Product | Description | Indication | Action/Date |
Alza Corp. | Doxil (FDAapproved) | Doxorubicin HCl liposome injection | Refractory ovarian cancer | Oncologic Drugs Advisory Committee recommended approval of supplemental NDA (6/8) |
Chiroscience Group plc (UK) | Chirocaine | Levobupivacaine; chiral version of approved drug bupivacaine | Broad usage in local, regional or spinal anesthesia | FDA's Anesthetics and Life Support Drugs Advisory Committee voted unanimously to recommend approval (1/12) |
Ciba Vision (a subsidiary of Novartis AG) and QLT PhotoTherapeutics Inc. | Visudyne | Verteporfin; lightactivated drug for photodynamic therapy | Wet age-related macular degeneration | FDA advisory panel recommended approval (11/17) |
Digene Corp. | Hybrid Signal Capture test for cytomegalovirus | Amplification test for cytomegalovirus DNA and RNA | Detection of cytomegalovirus infection | Microbiology Devices Panel voted to allow identification of product as signal amplification assay, which allows for higher reimbursement (5/21) |
Ligand Pharmaceuticals Inc. | Targretin capsules | Bexarotene; synthetic retinoid X receptors; oral formulation | Advanced-stage cutaneous T-cell lymphoma | Oncologic Drugs Advisory Committee recommended marketing approval (12/13) |
Merck & Co. Inc. | Vioxx | Rofecoxib; specific inhibitor of cyclooxygenase-2 | Osteoarthritis and relief of acute pain | FDA's Arthritis Advisory Committee recommended approval, with standard gastrointestinal warning for nonsteroidal antiinflammatory drugs (4/20) |
Scios Inc. and Bayer AG (Germany) | Natrecor | Nesiritide; human Btype natriuretic peptide (BNP; naturally occurring hormone produced in the heart) | Short-term management of congestive heart failure | FDA's Cardiovascular and Renal Drugs Advisory Committee recommended approval (1/29) |
U.S. Bioscience and Alza Corp. | Ethyol | Amifostine; selective cytoprotective agent | Moderate-to-severe post-operative, radiation-induced xerostomia in patients undergoing radiation treatment for head and neck cancer | Oncologic Drugs Advisory Committee recommended approval (6/9) |
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