The FDA has licensed Adacel (Aventis Pasteur) and Boostrix (GlaxoSmithKline), two new combination vaccines that include tetanus toxoid, diphtheria toxoid and acellular pertussis antigens (Tdap), for use as a booster in adolescents and adults. In the past, older children and adults were not re-immunized against pertussis because of concerns about reactions to the whole-cell vaccine previously used in younger children. The CDC Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) have recommended that either of the new Tdap vaccines replace routine...

Insulin detemir (Levemir - Novo Nordisk) is the second long-acting basal insulin analog to be marketed in the US for treatment of both type 1 and type 2 diabetes. Detemir differs from human insulin by the elimination of the amino acid threonine in position B30 and the addition of a 14-carbon fatty acid chain at position B29. Insulin glargine (Lantus), the first long-acting insulin analog, has been available since 2001 and is usually given once daily.1 NPH insulin is an intermediate-acting basal insulin given twice daily. Basal insulins are usually combined with prandial doses of a rapid-acting...

Sunitinib (Sutent - Pfizer) and sorafenib (Nexavar - Bayer), two oral tyrosine kinase inhibitors, have been approved by the FDA for treatment of advanced renal cell carcinoma (RCC). Sunitinib is also approved for use in patients with gastrointestinal stromal tumor (GIST) who are not responding to or are intolerant of standard therapy with imatinib (Gleevec).

Paliperidone (Invega - Janssen) has been approved by the FDA in an extended-release formulation for treatment of schizophrenia. It is the primary active metabolite of the second-generation antipsychotic risperidone (Risperdal - Janssen), which is scheduled to lose its patent exclusivity in December 2007.

MoviPrep (Salix) is a new polyethylene glycol (PEG)-based bowel cleansing preparation approved for use in adults prior to colonoscopy. It contains ascorbic acid, which acts as an additional cathartic and flavoring agent, and requires a lower volume of fluid (3 L compared to the traditional 4 L) than most other PEG products. HalfLytely is an FDA-approved 2-L PEG product, but it must be taken with bisacodyl.

The FDA has approved the marketing of desvenlafaxine (Pristiq - Wyeth), the main active metabolite of venlafaxine (Effexor, and others - Wyeth), for treatment of major depressive disorder. Venlafaxine, a norepinephrine and serotonin reuptake inhibitor (SNRI), is available generically as an immediate-release tablet. Venlafaxine extended-release capsules (Effexor XR) are scheduled to go off-patent in 2010.

The FDA has approved the proton-pump inhibitor (PPI) dexlansoprazole (Kapidex - Takeda), a delayed release formulation of the R-enantiomer of lansoprazole (Prevacid - Takeda), for treating and maintaining healing of erosive esophagitis and for treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD).

Dronedarone (Multaq - Sanofi-Aventis) has been approved by the FDA for oral treatment of atrial fibrillation and flutter. Amiodarone (Cordarone, and others) is the most effective drug for this indication, but has considerable toxicity.

The FDA has approved degarelix (Firmagon - Ferring), a synthetic decapeptide gonadotropin-releasing hormone (GnRH) receptor antagonist, for rapid medical castration of men with advanced prostate cancer. Abarelix (Plenaxis), the first GnRH antagonist approved by the FDA, was withdrawn from the US market because of immediate hypersensitivity reactions.

The FDA has approved the fluoroquinolone besifloxacin 0.6% ophthalmic suspension (Besivance - Bausch & Lomb) for treatment of bacterial conjunctivitis caused by susceptible bacteria. According to the manufacturer, this product was developed specifically for ophthalmic use in a specialized vehicle designed to prolong contact time on the ocular surface. Besifloxacin is not available for systemic use.