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)