Jane S. Ricciuti, RPh, MS


August 28, 2003

In This Article


The US Food and Drug Administration (FDA) has approved 2 new antiviral agents for HIV infection -- Emtriva (emtricitabine) and Reyataz (atazanavir). Emtricitabine is a synthetic nucleoside analogue and atazanavir is an azapeptide inhibitor.

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

Alzheimer's Disease Agents

  • Cognex (tacrine) Capsules

Antiasthmatic Agents

  • Foradil (formoterol fumarate) Aerolizer Inhalation Powder

Antihemophilic Product

  • Advate (Antihemophilic Factor [Recombinant], Plasma/Albumin Free Method [rAHF-PFM])

Antihypertensive Agents

  • Cardura (doxazosin mesylate) Tablets

Anti-infective Agents

  • Lariam (mefloquine hydrochloride) Tablets

Antineoplastic Agents

  • Bexxar (tositumomab and Iodine I 131 tositumomab)

Antiviral Agents

  • Emtriva (emtricitabine) Capsules

  • Reyataz (atazanavir sulfate) Capsules

Cardiovascular Agents

  • Pravigard PAC (copackaged 20, 40 or 80 mg pravastatin sodium and 81 or 325 mg buffered aspirin) Tablets


  • Premarin (conjugated estrogens) Tablets

Growth Hormones

  • Humatrope (somatropin, rDNA origin) Injection

Pulmonology Agents

  • Zemaira (alpha-1-proteinase inhibitor [human] Intravenous Injection

Rheumatologic Agents

  • Kineret (anakinra) Injection

  • Enbrel (etanercept) Injection

Urology Agents

  • Uroxatral (alfuzosin hydrochloride) Extended Release Tablets


  • Infanrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)


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