Ceftibuten (Cedax - Schering), an oral cephalosporin similar to cefixime (Suprax - Medical Letter, 31:73, 1989), has been approved by the US Food and Drug Administration (FDA) for treatment of acute otitis media, pharyngitis or tonsillitis, and for acute bacterial exacerbations of chronic bronchitis.

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.

The FDA has approved the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence – AstraZeneca) for oral treatment of relapsed or refractory mantle cell lymphoma. Acalabrutinib is the second BTK inhibitor to be approved for this indication; ibrutinib (Imbruvica) was approved in 2013.Ibrutinib inhibits other kinases in addition to BTK and has been associated with severe adverse effects, particularly atrial fibrillation, infection, rash, and bleeding, that may be related to inhibition of kinases other than BTK.1 Acalabrutinib is a more selective BTK inhibitor than ibrutinib; whether...

The CDC has issued new recommendations for treatment of gonococcal infection. A single 500-mg IM dose (1000 mg in patients weighing ≥150 kg) of the third-generation cephalosporin ceftriaxone is now the treatment of choice for patients with uncomplicated urogenital, rectal, or pharyngeal gonorrhea.

The FDA has authorized use of the Visby Medical Women's Sexual Health Test (Visby), an at-home test available without a prescription, for detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections in women with and without symptoms. It is the first test to become available in the US for these sexually transmitted infections (STIs) that can be performed entirely at home. Other at-home tests are available in the US for diagnosis of chlamydia, gonorrhea, and trichomoniaisis, but they require mailing a urine or blood sample to a...

The FDA has reported that 5106 elderly patients with dementia treated with atypical (second generation) antipsychotics in 17 randomized controlled trials had a higher mortality rate (4.5% vs. 2.6%) than those receiving placebo. Most of the deaths were due to cardiovascular and infectious causes (such as pneumonia). The drugs used in the trials were aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal). As the increase in mortality was considered a class effect, the FDA advisory also included ziprasidone (Geodon), clozapine (Clozaril) and the...

The FDA recently approved ixazomib (Ninlaro – Takeda), daratumumab (Darzalex – Janssen Biotech), and elotuzumab (Empliciti – BMS) for treatment of relapsed and/or refractory multiple myeloma.

The FDA has approved Otovel (Arbor), a combination of the fluoroquinolone antibiotic ciprofloxacin 0.3% and the corticosteroid fluocinolone acetonide 0.025%, for otic treatment of acute otitis media with tympanostomy tubes (AOMT) in children ≥6 months old. It is the second fluoroquinolone/corticosteroid combination to be approved for this indication; ciprofloxacin 0.3%/dexamethasone 0.1% (Ciprodex) has been available for many years. In December 2015, a suspension of ciprofloxacin 6% (Otiprio) was approved for otic treatment of bilateral otitis media with effusion in children...

The FDA has approved the oral kinase inhibitor quizartinib (Vanflyta – Daiichi Sankyo) for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy in adults with FLT3 internal tandem duplication (ITD)-positive, newly-diagnosed acute myeloid leukemia (AML).

The FDA has approved Trelegy Ellipta (GSK), a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate, the long-acting antimuscarinic agent (LAMA) umeclidinium, and the long-acting beta₂-agonist (LABA) vilanterol. It is available as a dry powder inhaler for once-daily maintenance treatment of COPD and to reduce COPD exacerbations in patients with a history of exacerbations. Trelegy Ellipta is the first three-drug inhaler for treatment of COPD to become available in the US.