Jane S. Ricciuti, RPh, MS


May 27, 2003

In This Article


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

Antihypertensive Agents

  • Cozaar (losartan) Tablets

Anti-infective Agents

  • Factive (gemifloxacin) Tablets

  • Vfend (voriconazole) Tablets and Powder for Injection

  • Zagam (sparfloxacin) Tablets

Antilipemic Agents

  • Zocor (simivastatin) Tablets

Endocrinologic Agents

  • Aldurazyme (laronidase) Injection

  • Fabrazyme (agalsidase beta) Injection

Gastroenterology Agents

  • Remicade (infliximab) Injection

Immunosuppressive Agents

  • Rapamune (sirolimus) Oral Solution & Tablets

Ophthalmic Agents

  • Zymar (gatifloxacin) Ophthalmic Solution

Surgical Agents

  • Crosseal (fibrin sealant [human]) Topical


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