The FDA has approved efinaconazole 10% solution (Jublia – Valeant) for topical treatment of toenail onychomycosis due to Trichophyton rubrum and/or Trichophyton mentagrophytes. It is the first topical triazole antifungal drug to be approved for this indication. A topical oxaborole antifungal solution, tavaborole 5% (Kerydin – Anacor), also recently approved by the FDA for the same indication will be reviewed in a future issue.

The FDA has approved Incruse Ellipta (GSK), a single-agent inhaler containing the long-acting anticholinergic umeclidinium, for once-daily maintenance treatment of chronic obstructive pulmonary disease (COPD). Umeclidinium was initially approved in combination with the long-acting beta₂-adrenergic agonist vilanterol as Anoro Ellipta.

Lifileucel (Amtagvi – Iovance), a tumor-derived autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a mitogen-activated kinase (MEK) inhibitor. It is the first cellular therapy to be approved for use in solid tumors. Accelerated approval of lifileucel was based on objective response rates.

The FDA has approved tebentafusp-tebn (Kimmtrak – Immunocore), a first-in-class bispecific gp100 peptide-HLA-directed CD3 T-cell engager, for treatment of HLA-A*02:01-positive unresectable or metastatic uveal melanoma in adults.

Proton pump inhibitors (PPIs), which are used for treatment of gastroesophageal reflux disease (GERD) and for prevention of upper gastrointestinal adverse effects caused by NSAIDs and aspirin, are one of the most commonly prescribed classes of drugs in the US. All PPIs are similarly effective and generally well tolerated, but their long-term use has been associated with a number of safety concerns. Recommendations addressing these concerns have recently been published.

Arformoterol tartrate (Brovana - Sepracor), a singleisomer, long-acting beta₂-agonist, has been approved by the FDA as an inhalation solution for nebulization for treatment of bronchoconstriction pulmonary disease (COPD). Arformoterol is the (R,R)-enantiomer of formoterol (Foradil), which is available as a powder for inhalation and was recently also approved as a solution for nebulization (Perforomist - Dey; available fall 2007)

The antiplatelet agents aspirin and clopidogrel (Plavix, and others) are used in most patients undergoing percutaneous coronary intervention (PCI) to prevent stent thrombosis and to reduce the occurrence of peri-, post-procedural and late cardiovascular events. Despite a large number of randomized trials of these agents in such patients, the optimal dosage and duration of treatment with these drugs, and whether other drugs should be added, is unclear.

Ziac (Lederle), a combination of the beta-blocker bisoprolol fumarate and a very low dose (6.25 mg) of the diuretic hydrochlorothiazide, has been approved for treatment of hypertension by the US Food and Drug Administration (FDA). Bisoprolol, a new cardioselective beta-blocker with no intrinsic sympathomimetic activity, has also been marketed as a single drug (Zebeta - Lederle). The manufacturer is promoting the combination for initial treatment of hypertension with the claim that the low doses of the two drugs used together are effective in lowering blood pressure, but are each too low ...

Torsemide, a new loop diuretic similar in action to bumetanide (Bumex) and furosemide, was recently approved by the US Food and Drug Administration for treatment of edema due to congestive heart failure, renal disease, or hepatic disease and also for treatment of hypertension. It is available for both oral and intravenous use.

The US Food and Drug Administration has approved the marketing of 5% doxepin hydrochloride cream (Zonalon - GenDerm) for treatment of pruritus due to eczematous dermatoses. Oral doxepin is used as a tricyclic antidepressant (Sinequan, and others).