Fluoxetine (Prozac - Dista), a phenylpropylamide, is the first serotonin-reuptake blocker introduced in the USA for treatment of . It is being promoted as causing fewer adverse effects than other antidepressants. Claims of greater safety and patient tolerability have often been made for new non-tricyclic antidepressants in recent years, but unpredicted adverse effects have emerged with widespread use, including priapism with trazodone (Desyrel - Medical Letter, 26:35, 1984) and fatal hemolytic anemia with nomifensine (Merital - Medical Letter, 27:73, 1985).

Terbinafine 1% cream (Lamisil - Sandoz), an allylamine synthetic antifungal drug chemically related to naftifine (Naftin - Medical Letter, 30:98, 1988), is now available in the USA for topical treatment of tinea pedis, tinea cruris, and tinea corporis infections. An oral formulation is available in Europe and is under investigation here.

Granisetron, a serotonin (5-HT) antagonist similar to ondansetron, was recently approved by the US Food and Drug Administration for prevention of nausea and vomiting due to cancer chemotherapy. Although available in an oral formulation in other countries, granisetron is available here only for intravenous (IV) use.

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.

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.

Dutasteride (Avodart - GlaxoSmithKline) is now available in the US for oral treatment of benign prostatic hyperplasia (BPH). It is similar to finasteride (Proscar - Merck), which has been marketed for this indication since 1992 and also, since 1998, for alopecia (Propecia - Medical Letter 1998; 40:25).

The InstaRead Lithium System (ReliaLAB), an office test that only requires a finger stick to measure lithium serum concentrations, has been cleared by the FDA and is now available. Standard methods for measuring lithium serum concentrations require venipuncture and transport of the specimen to commercial laboratories.

In 2012, the FDA required manufacturers of HMG-CoA reductase inhibitors (statins) to add a warning to their labels about reports of increased blood glucose and glycosylated hemoglobin (HbA1c) levels. Since then, several new studies have been published.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali – Novartis) has been approved by the FDA for use in combination with an aromatase inhibitor for first-line endocrine-based therapy in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Ribociclib is also available copackaged with the aromatase inhibitor letrozole (Femara, and generics) as Kisqali Femara Co-Pack. Ribociclib is the second CDK 4/6 inhibitor to be approved in the US for this indication;...

The FDA has approved the HMG-CoA reductase inhibitor (statin) pitavastatin magnesium (Zypitamag – Zydus) for use in adults with primary hyperlipidemia or mixed dyslipidemia. The FDA considers pitavastatin magnesium bioequivalent to pitavastatin calcium (Livalo), which was approved in 2009.1Statins remain the treatment of choice for most patients who require lipid-lowering therapy. Taken as an adjunct to diet modification, increased exercise, and smoking cessation, statins can reduce the risk of primary and secondary cardiovascular events and death in patients with or at high risk for...