Cefditoren pivoxil (Spectracef — TAP), a new oral third-generation cephalosporin, has been approved by the FDA for treatment of acute exacerbations of chronic bronchitis, pharyngitis, tonsillitis and uncomplicated skin and soft tissue infections in adults and children 12 or more years old. The drug has been used in Japan for 7 years.

Bortezomib (PS341; Velcade Millenium), the first proteasome inhibitor, has received accelerated approval from the FDA for treatment of refractory multiple myeloma. This review includes descriptions of the mechanism of action, pharmacokinetics, adverse effects, and dosage and cost of bortezomib, outlines the results of clinical studies, and concludes with an overall assessment of the drug's effectiveness.

A large mumps outbreak that began in Iowa in December 2005 has spread. About 40% of the cases have been in people 18-25 years old, many of whom are college students and had been vaccinated against the disease.

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 extended-release formulation of oxycodone and acetaminophen (Xartemis XR – Mallinckrodt) for oral treatment of acute pain severe enough to require an opioid. Oxycodone is available in the US as a single entity in oral immediate-release (Oxecta, and others) and extendedrelease (OxyContin) formulations. Immediate-release oxycodone is also available in combination with aspirin (Percodan, and others), acetaminophen (Percocet, and others), or ibuprofen (see Table 1).

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.

The FDA has approved ibalizumab-uiyk (Trogarzo – Theratechnologies/TaiMed), a CD4-directed monoclonal antibody, for IV treatment of multidrug-resistant HIV-1 (MDR-HIV) infection in heavily antiretroviral-experienced adults with treatment failure on their current regimen. Ibalizumab-uiyk is the first biologic drug to be approved by the FDA for treatment of HIV-1 infection.

The FDA has approved hydrogen peroxide 40% topical solution (Eskata – Aclaris Therapeutics) for treatment of raised seborrheic keratoses (SKs) in adults. It is the first drug to be approved for this indication. (Hydrogen peroxide is available over the counter for topical use as a 3% solution.)

A reader has questioned why the label for the COX-2 selective NSAID celecoxib (Celebrex, and generics), which contains a sulfonamide moiety, states that it is contraindicated for use in patients with an allergy to sulfonamides, while the labels of some other sulfonamide drugs recommend either caution or no precautions at all. The concept of cross-reactivity among sulfonamide drugs, particularly between antibacterial and nonantibacterial sulfonamides, has been controversial for many years.

Maribavir (Livtencity – Takeda), an oral cytomegalovirus (CMV) pUL97 kinase inhibitor, has been approved by the FDA for treatment of post-transplant CMV infection refractory to standard antiviral therapy in patients ≥12 years old who weigh at least 35 kg.