BioWorld
www.bioworld.com/articles/479995

Products Recommended For Approval By FDA Advisory Panels In 1999

Jan. 1, 2000

CompanyProductDescriptionIndicationAction/Date
Alza Corp.Doxil (FDAapproved)Doxorubicin HCl liposome injectionRefractory ovarian cancerOncologic Drugs Advisory Committee recommended approval of supplemental NDA (6/8)
Chiroscience Group plc (UK)ChirocaineLevobupivacaine; chiral version of approved drug bupivacaineBroad usage in local, regional or spinal anesthesiaFDA'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.VisudyneVerteporfin; lightactivated drug for photodynamic therapyWet age-related macular degenerationFDA advisory panel recommended approval (11/17)
Digene Corp.Hybrid Signal Capture test for cytomegalovirusAmplification test for cytomegalovirus DNA and RNADetection of cytomegalovirus infectionMicrobiology Devices Panel voted to allow identification of product as signal amplification assay, which allows for higher reimbursement (5/21)
Ligand Pharmaceuticals Inc.Targretin capsulesBexarotene; synthetic retinoid X receptors; oral formulationAdvanced-stage cutaneous T-cell lymphomaOncologic Drugs Advisory Committee recommended marketing approval (12/13)
Merck & Co. Inc.VioxxRofecoxib; specific inhibitor of cyclooxygenase-2Osteoarthritis and relief of acute painFDA's Arthritis Advisory Committee recommended approval, with standard gastrointestinal warning for nonsteroidal antiinflammatory drugs (4/20)
Scios Inc. and Bayer AG (Germany)NatrecorNesiritide; human Btype natriuretic peptide (BNP; naturally occurring hormone produced in the heart)Short-term management of congestive heart failureFDA's Cardiovascular and Renal Drugs Advisory Committee recommended approval (1/29)
U.S. Bioscience and Alza Corp.EthyolAmifostine; selective cytoprotective agentModerate-to-severe post-operative, radiation-induced xerostomia in patients undergoing radiation treatment for head and neck cancerOncologic Drugs Advisory Committee recommended approval (6/9)