Jane S. Ricciuti, RPh, MS


January 29, 2004

In This Article


The US Food and Drug Administration (FDA) approved Cialis (tadalafil) in November 2003. Tadalafil is the third oral selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) approved for use in erectile dysfunction. Tadalafil was studied in over 4000 patients and demonstrated a treatment effect that did not diminish over time.

Also approved in November was Plenaxis (abarelix), a new agent for the palliative treatment of men with advanced symptomatic prostate cancer. The abarelix approval includes a limited distribution program as part of its risk management program to inform prescribers of the potential for severe allergic reactions.

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

Anti-infective Agents

  • VFEND (voriconazole) Tablets & Injection

Cardiovascular Agents

  • Tenormin (atenolol) Tablets

Immune Globulin

  • BabyBIG (botulism immune globulin intravenous [human])

Oral Contraceptives

  • Ovcon 35 (norethindrone and ethinyl estradiol)

Pulmonology Agents

  • Advair Diskus (fluticasone propionate/salmeterol) Inhalation Powder

Rheumatologic Agents

  • Arava (leflunomide)

Urologic Agents

  • Cialis (tadalafil) Tablets

  • Plenaxis (abarelix) Injectable Suspension