September 2004
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