Nateglinide (Starlix), a new meglitinide oral glucose-lowering agent, has been approved by the FDA.

Esomeprazole magnesium (Nexium - AstraZeneca), the S-isomer of omeprazole (Prilosec), is the fifth benzimidazole proton pump inhibitor to become available in the United States. Omeprazole, which was the first, is going off patent this year.

Imatinib mesylate (STI-571; Gleevec - Novartis), an oral tyrosine kinase inhibitor, has received accelerated approval from the FDA for treatment of all phases of chronic myeloid leukemia (CML) after interferon has failed.

Insulin Glargine (Lantus) is a new long-acting human insulin analog approved by the FDA for treatment of both type 1 and type 2 diabetes. Synthesized by recombinant DNA technology, it differs from human insulin at position 21 in the A-chain where asparagine is replaced by glycine and at the C-terminus of the B-chain where two arginines are added.

Darbepoetin alfa (Aranesp) has been approved by the FDA for treatment of anemia caused by chronic renal disease and will probably also be approved for use in patients with cancer..

Ertapenem (er ta pen' em; Invanz - Merck), a carbapenem antibacterial with a narrower spectrum of activity than imipenem (Primaxin) or meropenem (Merrem), has been approved by the FDA for once-daily IV treatment of complicated intra-abdominal, urinary tract and skin and skin structure infections, acute pelvic infections, and community-acquired pneumonia.

Bosentan (Tracleer - Actelion), a non-peptide endothelin receptor antagonist, has been approved by the FDA for oral treatment of patients who have pulmonary arterial hypertension (PAH) with symptoms of dyspnea at rest or with minimal exertion.

Valdecoxib (Bextra - Pharmacia/Pfizer), a selective cyclooxygenase (COX-2) inhibitor similar to celecoxib (Celebrex) and rofecoxib (Vioxx), was recently approved by the FDA for treatment of osteoarthritis, rheumatoid arthritis and primary dysmenorrhea.

Implanon (Organon), an implantable contraceptive containing the progestin etonogestrel, has been approved by the FDA. Two other implantable contraceptives, Norplant and Jadelle, which both contain levonorgestrel, are FDA-approved but not marketed in the US.

The antiplatelet drug clopidogrel (Plavix, and others) reduces major cardiovascular events, but can cause bleeding. Proton pump inhibitors (PPIs) are often used with clopidogrel to prevent gastrointestinal bleeding, however, some evidence suggests that PPIs may interfere with the activation of clopidogrel and diminish its antiplatelet effect. FDA-approved labeling recommends avoiding concurrent use of the PPIs omeprazole and esomeprazole with clopidogrel.