Mibefradil dihydrochloride (Posicor - Roche), a chemically distinct nondihydropyridine calcium-channel blocker, has been approved by the US Food and Drug Administration (FDA) and is being heavily promoted as the first T-type calcium-channel blocker for treatment of hypertension and chronic stable angina.

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.

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.

Montelukast (Singulair - Merck), a leukotriene receptor antagonist already marketed for asthma (Treatment Guidelines from The Medical Letter 2002; 1:11), has been approved by the FDA for treatment of seasonal allergic rhinitis in adults and children more than 2 years old.

Angiotensin receptor blockers (ARBs) are widely used as an alternative to angiotensin converting enzyme (ACE) inhibitors for treatment of hypertension because they lower blood pressure without inducing a cough. It has not been established that they provide the same cardiac benefits as ACE inhibitors. Recently, an editorial in the British Medical Journal suggested that ARBs may increase the risk of myocardial infarction.

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.

Temsirolimus (Torisel - Wyeth), an mTOR (mammalian target of rapamycin) kinase inhibitor that is metabolized to sirolimus (rapamycin), has been approved by the FDA for intravenous treatment of advanced renal cell carcinoma.

The treatment of choice to prevent emesis due to highand moderate-risk emetogenic drugs used in cancer chemotherapy is aprepitant plus a serotonin receptor antagonist plus dexamethasone. Four serotonin receptor antagonists are available in the US in intravenous (IV) formulations for prevention of nausea and vomiting due to cancer chemotherapy, and 3 of these are also available for oral use. Now the FDA has approved one of these, granisetron, in a transdermal formulation (Sancuso - ProStrakan).

The FDA has approved artemether-lumefantrine (Coartem - Novartis) for oral treatment of uncomplicated Plasmodium falciparum malaria. It is not approved for prophylaxis. Artemether-lumefantrine is the first artemisinin-based drug approved for use in the US. Artemisinins are Chinese herbal products used worldwide to treat malaria. The intravenous formulation of artesunate, another artemisinin, is available in the US through the CDC.

The FDA has approved the use of tranexamic acid (Lysteda – Ferring), an oral antifibrinolytic, for treatment of menorrhagia. Tranexamic acid has been used for this purpose in Europe for decades, and is available without a prescription in some countries. It has been available in the US since 1987 for use with coagulation factors in patients with hemophilia undergoing dental extractions.