The FDA has approved Xacduro (Innoviva), a combination of the beta-lactam antibacterial sulbactam and the beta-lactamase inhibitor durlobactam, for IV treatment of adults with hospital-acquired or ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (ABC).

The FDA has approved Biktarvy (Gilead), a once-daily, fixed-dose combination of bictegravir, a new integrase strand transfer inhibitor (INSTI), and the nucleoside reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir alafenamide (TAF), for treatment of HIV-1 infection in adults. The new combination is indicated for use in patients who are antiretroviral-naive or who have been virologically suppressed on a stable antiretroviral regimen for ≥3 months with no history of treatment failure and no known substitutions associated with resistance to any component of the...

Influenza is generally a self-limited illness, but pneumonia, respiratory failure, and death can occur, especially in persons at increased risk for influenza complications (see Table 1). Updated information on influenza activity and antiviral resistance is available from the CDC at cdc.gov/flu.

Recombinant interferon alfa-2b (Intron A - Schering) was recently approved by the US Food and Drug Administration (FDA) for intralesional treatment of genital warts (condylomata acuminata). Interferon was previously available only for treatment of hairy-cell leukemia (Medical Letter, 28:78, 1986).

The FDA has approved a subcutaneous formulation of the recombinant human anti-CD20 antibody ofatumumab (Kesimpta – Novartis) for treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). Kesimpta is the second anti-CD20 antibody to be approved for these indications; IV ocrelizumab (Ocrevus), which is also approved for treatment of primary progressive MS, was the first. An IV formulation of ofatumumab (Arzerra) has...

The FDA has approved dolutegravir (doll-you-TEG-rah-veer; Tivicay – Viiv Healthcare), an integrase strand transfer inhibitor (INSTI), for treatment of HIV-1 infection in adults and in children ≥12 years old who weigh at least 40 kg. It is the third INSTI to be approved by the FDA; raltegravir and elvitegravir were approved earlier.

The FDA has approved secnidazole oral granules (Solosec – Symbiomix/Lupin) for single-dose treatment of bacterial vaginosis (BV) in adult women.

Mupirocin (Bactroban - Beecham), a topical antibiotic formerly called pseudomonic acid, was recently approved by the US Food and Drug Administration for treatment of impetigo. It will be sold as a 2% ointment available only by prescription.

A new Haemophilus influenzae type b capsular polysaccharide vaccine conjugated with diphtheria toxoid (ProHIBiT - Connaught) was recently marketed in the USA. It is being promoted as a replacement for older, unconjugated H. influenzae vaccines (b- Capsa I; Hibimune; HibVAX) previously reviewed in The Medical Letter (Volume 27, page 61, 1985).

Itraconazole (Sporanox - Janssen), an oral antifungal triazole that has been available in the USA since 1992 for treatment of deep fungal infections (Medical Letter, 35:7, 1993), is now being marketed for treatment of dermatophyte infections of the toenails, with or without fingernail involvement.