SPOTLIGHT -
FDA actions In Brief
FDA actions in brief reported November 1, 2001
PEG-Intron (Peginterferon alfa-2b powder for injection) Schering
Combination use with ribavirin for chronic hepatitis C
Foradil Aerolizer (Formoterol fumarate inhalation powder)
New Indication: Maintenance treatment of COPD
Aranesp (Darbepoetin alfa for injection) Amgen
NMEs/biologics: Longer-lasting erythropoietin product for anemia related to renal failure
Cathflo Activase (Alteplase) Genentech
New Indication: Low-dose t-PA for catheter clearance
Zometa (Zoledronic acid for injection) Novartis
NMEs/biologics:Short-infusion bisphosphonate for hypercalcemia of malignancy
FDA Actions in Brief
FDA Actions in Brief as reported September 1, 2001
