Alemtuzumab (Campath), a genetically engineered, humanized monoclonal antibody currently approved to treat B-cell chronic lymphocytic leukemia (BCLL) and used off-label for induction therapy in solid organ transplants, is now also being tried off-label for treatment of relapsing multiple sclerosis (MS).

Darunavir (Prezista - Tibotec), a new protease inhibitor, has received accelerated approval from the FDA for use in combination therapy of human-immunodeficiency virus (HIV) infection in previously treated adults. It is coadministered with low-dose ritonavir (Norvir), which increases its bioavailability.

Telaprevir (Incivek – Vertex) and boceprevir (Victrelis – Merck) have been approved by the FDA for oral use in combination with peginterferon and ribavirin for treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adults with compensated liver disease. Both telaprevir and boceprevir were developed specifically to inhibit the NS3/4A proteases that cleave HCV encoded polyproteins of the genotype 1 virus.

A fixed-dose combination of atovaquone and proguanil hydrochloride has been approved by the FDA for oral prophylaxis and treatment of malaria due to Plasmodium falciparum, including choloroquine-resistant strains.

The FDA has approved the marketing of the corticosteroid ciclesonide (Alvesco - Sepracor) in a hydrofluoroalkane (HFA) metered-dose inhaler formulation for maintenance treatment of asthma in patients >12 years old. Ciclesonide is also available in the US as a nasal spray for allergic rhinitis (Omnaris), and has been available for asthma in Europe since 2003.

The FDA has approved the marketing of certolizumab pegol (Cimzia - UCB), a tumor necrosis factor (TNF) blocker, for treatment of moderate to severe Crohn's disease refractory to conventional treatment. It is the third TNF blocker approved for this indication.

The FDA has approved Ryaltris (Hikma), a fixed-dose combination nasal spray containing the H1-antihistamine olopatadine hydrochloride (Patanase, and generics) and the corticosteroid mometasone furoate (Nasonex 24 HR Allergy, and generics), for treatment of seasonal allergic rhinitis symptoms in persons ≥12 years old. Ryaltris is the second intranasal antihistamine/corticosteroid combination to be approved for this indication; azelastine 0.1%/fluticasone propionate (Dymista, and generics), which is approved for use in persons ≥6 years old, was the first. Both products are available...

Clozapine (Clozaril - Sandoz), an antipsychotic drug, was first marketed in the USA three years ago (Medical Letter, 32:3, 1990). Because of its hematological toxicity, the US Food and Drug Administration approved the drug only for patients with schizophrenia who cannot tolerate or do not respond to standard antipsychotic drugs.

Itraconazole (Sporanox - Janssen), an antifungal triazole, has been approved by the US Food and Drug Administration (FDA) for oral treatment of histoplasmosis and blastomycosis. These two endemic mycoses occur both in normal hosts and in immunocompromised patients, such as those with AIDS (RW Bradsher, Clin Infect Dis, 14:S82, 1992; LJ Wheat, Clin Infect Dis, 14:S91, 1992).

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.