March 2003

Jane S. Ricciuti, RPh, MS

March 19, 2003

Introduction

In February 2003, the United States Army received Food and Drug Administration (FDA) approval for pyridostigmine bromide under new regulations that do not require human efficacy studies. As part of the FDA's initiative for countering bioterrorism, the agency is focusing on the expeditious development and licensing of products to diagnose, treat, or prevent outbreaks from exposure to pathogens that have been identified as bioterrorism agents. Pyridostigmine was granted limited approval for use by US military personnel to increase survival after exposure to the nerve agent soman.

This month's column reviews FDA new product approvals and labeling changes for:

Antiasthmatic Agents

Pulmicort Respules (budesonide inhalation suspension)

Antidepressants

Effexor XR (venlafaxine hydrochloride) Extended Release Capsules

Antineoplastic Agents

Eligard (leuprolide acetate) Injection
Femara (letrozole) Tablets
Gliadel Wafer (polifeprosan 20 with carmustine implant)

Antiretroviral Agents

Zerit XR Extended-Release (stavudine) Capsules

Central Nervous System Agents

Permax (pergolide mesylate) Tablets

Dermatologic Agents

Finacea (azelaic acid) Gel, 15%

Immunosuppressive Agents

Sandimmune (cyclosporine)

Neurologic Agents

Avonex (interferon beta-1a)

Parasympathomimetic (Cholinergic)/Antibioterrorism Agents

Pyridostigmine bromide

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Next Section

Cite this: March 2003 - Medscape - Mar 20, 2003.

Table 1. *Femara* Clinical Data: First-line Breast Cancer
	32 Months Median Follow-up		18 Months Median Follow-up
	Femara 2.5 mg (n = 453)	Tamoxifen 20 mg (n = 454)	Femara 2.5 mg (n = 453)	Tamoxifen 20 mg (n = 454)
Median time to progression	9.4 months	6.0 months	9.4 months	6.0 months
Objective response rate (CR+PR)	145 (32%)	95 (21%)	137 (30%)	92 (20%)
CR	42 (9%)	15 (3%)	34 (8%)	13 (3%)
Duration of objective response	18 months (n = 145)	16 months (n = 95)
Overall survival	35 months (n = 458)	32 months (n = 458)

Table 2. *Femara* Clinical Data: First-line Breast Cancer -- Efficacy by Receptor Status
	Femara 2.5 mg	Tamoxifen 20 mg
Receptor Positive	n = 294	n = 305
Median time to progression	9.4 months	6.0 months
Objective response rate (CR+PR)	97 (33%)	66 (22%)
Receptor Unknown	n = 159	n = 149
Median time to progression	9.2 months	6.0 months
Objective response rate (CR+PR)	48 (30%)	29 (20%)

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March 2003

Introduction

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Tables

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Authors and Disclosures

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