Fluconazole (Diflucan - Roerig), an antifungal azole, was recently approved by the US Food and Drug Administration for oral and intravenous (IV) treatment of cryptococcal meningitis and various forms of candidiasis. Both cryptococcal meningitis and candidiasis occur frequently in patients with AIDS, organ transplants, or cancer.

Enoxacin (en ox' a sin; Penetrex - Rh ne-Poulenc Rorer), a fluoroquinolone antimicrobial for oral use, has now been marketed in the USA for treatment of urinary tract infections and uncomplicated urethral or cervical gonorrhea.

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.

Modafinil (Provigil - Cephalon; Alertec - Draxis in Canada), first approved by the FDA in 1999 for treatment of excessive daytime sleepiness associated with narcolepsy (Medical Letter 1999; 41:30), has now also been approved for treatment of patients with excessive sleepiness due to obstructive sleep apnea/hypopnea syndrome (OSAHS) or shift work sleep disorder (SWSD) (DSM-IV, text revision, Washington, DC: American Psychiatric Association, 2000, page 622).

Apriso (Salix) is a new formulation of mesalamine (5-aminosalicylic acid; 5-ASA) approved by the FDA for maintenance of remission in mild to moderate ulcerative colitis (UC). Mesalamine is a locally acting antiinflammatory agent that is widely used both to maintain and induce remission in inflammatory bowel disease. Various mesalamine formulations have been developed to target drug delivery to areas of the small intestine and colon. Most of these agents require frequent dosing and have a high pill burden. The newest products - Lialda, introduced in 2007,1 and now Apriso - can be dosed once...

The FDA has approved the use of aliskiren (Tekturna), a direct renin inhibitor, with valsartan (Diovan), an angiotensin-receptor blocker (ARB), in a fixed-dose combination as Valturna (Novartis) for treatment of hypertension in patients already taking both drugs or not adequately controlled on monotherapy, and as initial therapy in those likely to need multiple drugs to control their blood pressure.

The FDA has approved Duzallo (Ironwood), a fixed-dose combination of the uric acid transporter 1 (URAT1) inhibitor lesinurad (Zurampic) and the xanthine oxidase inhibitor allopurinol (Zyloprim, and generics), for once-daily treatment of gout-associated hyperuricemia in patients who have not achieved target serum uric acid levels with allopurinol alone.

The FDA has approved peanut allergen powder-dnfp (Palforzia – Aimmune) for use as oral immunotherapy to mitigate allergic reactions, including anaphylaxis, caused by accidental peanut exposure in patients with a confirmed peanut allergy. It is the first drug to be approved in the US for this indication; Viaskin Peanut, an immunotherapy patch, is under FDA review for the same indication.

Teplizumab-mzwv (Tzield – Provention Bio), an anti-CD3 monoclonal antibody, has been approved by the FDA to delay the onset of stage 3 type 1 diabetes in patients ≥8 years old who have stage 2 type 1 diabetes. It is the first drug to become available in the US that delays the onset of type 1 diabetes.