September 2004

Jane S. Ricciuti, RPh, MS

September 16, 2004

Introduction

The US Food and Drug Administration (FDA) approved Cymbalta (duloxetine), a new selective serotonin and norepinephrine reuptake 5-inhibitor (SSNRI). Duloxetine is indicated for major depressive disorder.

New indications have been approved for Topamax (topiramate), Alimta (pemetrexed), Taxotere (docetaxel), Geodon (ziprasidone), Adderall XR (amphetamine/dextroamphetamine), Vioxx (rofecoxib), and Humira (adalimumab).

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

Anticonvulsants

Topamax (topiramate) Tablets and Capsules

Antidepressants

Cymbalta (duloxetine) Capsules

Antidiabetic Agents

Actos (pioglitazone) Tablets

Antineoplastic Agents

Alimta (pemetrexed) Injection
Taxotere (docetaxel) Injection

Antipsychotics

Geodon (ziprasidone) Capsules and Injection

Antivirals

Epzicom (abacavir/lamivudine) Tablets
Truvada (emtricitabine/tenofovir disoproxil) Tablets

CNS Stimulants

Adderall XR (amphetamine/dextroamphetamine)

Counterbioterrorism Agents

Pentetate (pentetate zinc and calcium trisodium) Injection

Nonsteroidal Anti-inflammatory Agents

Vioxx (rofecoxib) Tablets and Oral Suspension

Rheumatologic Agents

Humira (adalimumab) Injection

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Cite this: September 2004 - Medscape - Sep 16, 2004.

Table 1. Topamax (topiramate) Recommended Titration
	Morning Dose	Evening Dose
Week 1	None	25 mg
Week 2	25 mg	25 mg
Week 3	25 mg	50 mg
Week 4	50 mg	50 mg

Table 2. Rofecoxib Dosing
Pediatric Patients	Daily Dose
≥ 2 years to ≤ 11 years of age and ≥ 10 to < 42 kg	0.6 mg/kg to a maximum of 25 mg*
≥ 2 years to ≤ 11 years of age and ≥ 42 kg	25 mg
≥ 12 years to ≤ 17 years of age	25 mg
*Oral suspension dosage form is recommended. To improve dosing accuracy in smaller-weight children, the use of 12.5 mg/5 mL oral suspension (2.5 mg/mL) is recommended.

September 2004

Introduction

Tables

Tables

Authors and Disclosures

Authors and Disclosures

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