The US Food and Drug Administration (FDA) approved 2 new enzyme replacement products, Aldurazyme (laronidase) and Fabrazyme (agalsidase beta). Aldurazyme is indicated for patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I). Fabrazyme (agalsidase beta) is indicated for use in patients with Fabry disease.
This month's column reviews FDA new product approvals and labeling changes for:
Iprivask (desirudin) Injection
Cozaar (losartan) Tablets
Factive (gemifloxacin) Tablets
Vfend (voriconazole) Tablets and Powder for Injection
Zagam (sparfloxacin) Tablets
Zocor (simivastatin) Tablets
Aldurazyme (laronidase) Injection
Fabrazyme (agalsidase beta) Injection
Remicade (infliximab) Injection
Rapamune (sirolimus) Oral Solution & Tablets
Zymar (gatifloxacin) Ophthalmic Solution
Crosseal (fibrin sealant [human]) Topical
Medscape Pharmacists. 2003;4(1) © 2003 Medscape
Cite this: May 2003 - Medscape - May 28, 2003.