Ibandronate (Boniva - Roche) is the first bisphosphonate approved by the FDA for intravenous (IV) treatment of osteoporosis in postmenopausal women. It is given as a bolus injection once every 3 months. Ibandronate is also available as an oral once-a-month 150-mg tablet and as a daily 2.5-mg tablet.

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.

Since 2008, because of safety concerns, the FDA has mandated that long-term cardiovascular outcomes trials be conducted for all new drugs for type 2 diabetes. Reductions in the incidence of macrovascular complications in these trials with some sodium-glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists in patients at risk for cardiovascular disease (see Table 1) have led to new recommendations.

The FDA has approved a 4% aerosol foam formulation of minocycline (Amzeeq – Foamix) for topical treatment of inflammatory lesions of non-nodular moderate to severe acne in patients ≥9 years old. It is the first topical tetracycline formulation to be approved for use in patients with acne. Oral minocycline (Minocin, Solodyn, and generics) is

Faricimab-svoa (Vabysmo – Genentech), an inhibitor of both vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), has been approved by the FDA for intravitreal treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). It is the first drug to become available in the US that targets two pathways involved in maintaining vascular homeostasis. Several VEGF inhibitors are available for treatment of nAMD and DME (see Table 2).

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.