May 2003

Jane S. Ricciuti, RPh, MS

May 27, 2003

Introduction

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:

Anticoagulants

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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Cite this: May 2003 - Medscape - May 28, 2003.

Table 1. *Factive* (gemifloxacin) Dosing Regimen
Indication	Dose	Duration
Acute bacterial exacerbation of chronic bronchitis	One 320-mg tablet daily.	5 days
Community-acquired pneumonia (of mild to moderate severity)	One 320-mg tablet daily.	7 days

Table 2. HPS Summary Results
Endpoint	Zocor (N = 10,269) n (%)	Placebo (N = 10,267) n (%)	Risk Reduction (%)
Primary
Mortality	1328 (12.9)	1507 (14.7)	13
CHD mortality	587 (5.7)	707 (6.9)	18
Secondary
Nonfatal MI	357 (3.5)	574 (5.6)	38
Stroke	444 (4.3)	585 (5.7)	25
Tertiary
Coronary revascularization	513 (5)	725 (7.1)	30
Peripheral and other noncoronary revascularization	550 (4.4)	532 (5.2)	16

Table 3. Sirolimus Primary Endpoint Summary: Graft and Patient Survival (%)
Parameter	Rapamune With Cyclosporine Therapy (n = 215)	Rapamune Following Cyclosporine Withdrawal (n = 215)
Graft Survival
Month 12	95.8	97.2
Month 24	91.2	93.5
Month 36	85.1	91.2
Patient Survival
Month 12	97.2	98.1
Month 24	94.0	95.3
Month 36	88.4	93.5

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May 2003

Introduction

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