Jane S. Ricciuti, RPh, MS


April 22, 2003

In This Article


Three new agents that represent new classes have been approved by the US Food and Drug Administration (FDA). Fuzeon (enfuvirtide), Emend (aprepitant), and Somavert (pegvisomant) are novel agents recently approved by the FDA.

Enfuvirtide is the first in a new class of agents that inhibit the fusion of HIV-1 and CD4+ cells. Aprepitant is a neurokinin-1 receptor antagonist. Pegvisomant selectively binds to growth hormone (GH) receptors on cell surfaces, where it blocks the binding of endogenous GH.

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

Antidiabetic agents

  • Avandia (rosiglitazone maleate) Tablets


  • Emend (aprepitant) Capsules

Antihypertensive agents

  • Timolide (timolol maleate-hydrochlorothiazide) Tablets

Anti-infective agents

  • Avelox (moxifloxacin hydrochloride) Tablets and Avelox (moxifloxacin hydrochloride in NaCL) Injection

  • Lindane Lotion and Shampoo

  • Terazol 7 & 3 (terconazole) Vaginal Cream & Suppositories

Antineoplastic agents

  • Temodar (Temozolomide) Capsules

Antiviral agents

  • Fuzeon (enfuvirtide) Injection

  • Videx (didanosine) and Videx EC (didanosine)

Cardiovascular agents

  • Coreg (carvedilol)

Counterterrorism agents

  • Reactive Skin Decontamination Lotion (RSDL)


  • Midamor (amiloride HCl) and Moduretic (amiloride HCL/ hydrochlorothiazide)


  • Femring (estradiol acetate vaginal ring)

  • Prempro and Premphase (conjugated estrogens/medroxyprogesterone acetate) Tablets

Growth hormone receptor antagonists

  • Somavert (pegvisomant)

Immunosuppressive agents

  • CellCept (mycophenolate mofetil hydrochloride) Intravenous/Oral Suspension/Capsules/Tablets

Parasympathomimetic agents

  • Mytelase (ambenonium chloride) Capsules

Trace elements

  • Cupric Chloride Injection


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