Jane S. Ricciuti, RPh, MS


October 21, 2003

In This Article


In September, the US Food and Drug Administration (FDA) approved the first agent in a new class of antibiotics called cyclic lipopeptide antibacterial agents. Cubicin (daptomycin) is indicated for the treatment of complicated skin and skin structure infections caused by gram-positive microorganisms. Daptomycin binds to bacterial membranes and causes a rapid depolarization of membrane potential. The loss of membrane potential leads to inhibition of protein, DNA, and RNA synthesis, which results in bacterial cell death.

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

Antidiabetic Agents

  • Prandin (repaglinide) Tablets

Antidepressant Agents

  • Paxil CR (paroxetine HCl) Tablets

Anti-infective Agents

  • Cipro XR (ciprofloxacin) Extended-Release Tablets

  • Cleocin (clindamycin phosphate) Cream

  • Cubicin (daptomycin) for Injection

Antipsychotic Agents

  • Abilify (aripiprazole) Tablets

Antiviral Agents

  • Valcyte (valganciclovir HCI) Tablets

Cardiovascular Agents

  • Lopressor (metoprolol tartrate) Injection & Tablets

  • Lotrel (amlodipine and benazepril HCl) Capsules

Immune Globulin

  • Gamunex (Immune Globulin Intravenous [Human], 10% by Chromatography Process)

Oral Contraceptives

  • Seasonale (levonorgestrel/ethinyl estradiol) Tablets