Fosfomycin, a broad-spectrum antibiotic used parenterally in Europe for many years, has been approved by the US Food and Drug Administration (FDA) as fosfomycin tromethamine (Monurol - Forest) for single-dose oral treatment of uncomplicated urinary tract infections in women.

The antiestrogen toremifene (Fareston - Schering) and the selective aromatase inhibitor letrozole (Femara - Novartis) have been approved by the FDA for treatment of advanced breast cancer in postmenopausal women.

Cilostazol, a phosphodiesterase III inhibitor that has been used in Japan since 1988, has been approved by the FDA for treatment on intermittent claudication due to occlusive peripheral arterial disease.

Two cholesterol-lowering margarines have been marketed in the USA.

Balsalazide disodium (Colazal), a prodrug of mesalamine, was marketed in the US this year for oral treatment of mildly to moderately active ulcerative colitis. Oral formulations of mesalamine have been available in the US for nine years for treatment and maintenance of remissions and olsalazine, which is a dimer of mesalamine, is marketed for maintenance of remissions but not for treatment. Balsalazide has been available in Europe for four years.

Enfuvirtide (T-20; Fuzeon Trimeris/Roche), the first in a new class of HIV drugs known as fusion inhibitors, has received accelerated approval from the FDA for use with other antiretrovirals in adults and children with viral replication despite ongoing antiretroviral therapy. This review describes the mechanism of action and pharmacokinetics of the new drug, and outlines the results of the 2 clinical studies that led to its approval. Sections on adverse effects, development of resistance, and dosage and cost are also included. The review concludes with an overall assessment of the...

Trospium chloride (Sanctura - Indevus/Odyssey) has been approved by the FDA for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. It has been available in Europe for many years.

The FDA has approved a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) elvitegravir, the pharmacokinetic enhancer cobicistat, and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate (Stribild – Gilead) for treatment of HIV-1 infection in antiretroviral treament-naïve adults. Elvitegravir is the second INSTI to be approved by the FDA for use in HIV treatment; raltegravir (Isentress) was the first.

The FDA has approved a fixed-dose combination (Harvoni [har voe' nee] – Gilead) of sofosbuvir and ledipasvir (led' i pas' vir), two oral direct-acting antiviral agents, for treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Genotype 1 is responsible for 70-80% of HCV infections in the US. Sofosbuvir (Sovaldi) was approved earlier for use in combination with other antiviral drugs for treatment of HCV infection. Ledipasvir is a new drug.

The FDA has approved ferric citrate (Auryxia – Keryx), an oral phosphate binder, for treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. It is the second iron-based phosphate binder to be approved in the US, and the first that causes significant systemic absorption of iron. Auryxia is not FDA-approved for treatment of iron deficiency anemia.