Atomoxetine (Strattera - Lilly) is the first non-stimulant drug to be approved by the FDA for treatment of attention deficit hyperactivity disorder (ADHD). Unlike other drugs approved for use in ADHD, it is not a controlled substance and is approved for use in adults as well as children. Older non-stimulant drugs that have been used to treat ADHD, although not FDA-approved, include the alpha₂-agonist clonidine (Catapres, and others) and the tricyclic antidepressant desipramine (Norpramin, and others) (Medical Letter 1996; 38:109).

Improved glucose meters and 2 sensing systems for continuous monitoring have become available for management of diabetes.

Rifaximin (Xifaxan - Salix), a non-absorbed oral antibiotic derived from rifampin (Rifadin, and others), has been approved by the FDA for treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in patients 12 years of age or older. It has been available in Europe since 1987.

Bendamustine HCl (Treanda - Cephalon), an unusual DNA-alkylating agent that has been used in Europe for many years to treat lymphoma, has now been approved by the FDA for treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).

Silodosin (Rapaflo - Watson Pharmaceuticals), an alpha1a-adrenoreceptor selective antagonist, has been approved by the FDA for treatment of benign prostatic hyperplasia (BPH). Some medications for BPH are listed in the table on page 4. Alpha1 blockers are commonly used with 5a-reductase inhibitors such as finasteride, which can shrink the size of the prostate, but may take months to do so.

Infertility occurs in about 15% of couples. About one-third of cases are due to problems with ovulation or other female factors, another third are due to a male infertility factor, and the remaining third are unexplained. In older women, unexplained infertility is probably caused by diminished quality and quantity of oocytes. The first approach to treatment of female-factor infertility generally is the use of drugs that stimulate oocyte production.

The FDA has issued new warnings about the use of the opioid analgesics codeine and tramadol in children, particularly those <12 years old, and in breastfeeding women due to concerns about the risk of respiratory depression and death. The FDA previously issued warnings about these drugs in 2013 and 2015.

The FDA has approved Dovato (ViiV), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay) and the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (Epivir, and generics), as a once-daily complete regimen for treatment of adults with HIV-1 infection who are antiretroviral-treatment naive and have no known substitutions associated with resistance to either drug. Dolutegravir/lamivudine is the first complete regimen to be approved by the FDA for initial treatment of HIV-1 infection that contains 2 rather than 3 antiretroviral...

The FDA has approved two new drugs for sickle cell disease: crizanlizumab-tmca (Adakveo – Novartis), an IV P-selectin blocker, and voxelotor (Oxbryta – GBT), an oral hemoglobin S (HbS) polymerization inhibitor.

The FDA has approved the oral second-generation antipsychotic drug brexpiprazole (Rexulti – Otsuka/Lundbeck) for once-daily treatment of agitation associated with dementia due to Alzheimer's disease (AD). Brexpiprazole is the first drug to be approved in the US for this indication. It is also approved for treatment of schizophrenia and as an adjunct to antidepressants for treatment of major depressive disorder.