Jane S. Ricciuti, RPh, MS

Disclosures

September 16, 2004

In This Article

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

Comments

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