Topiramate (Topamax - Ortho-McNeil) has been approved by the US Food and Drug Administration (FDA) for oral use as an adjunct to other drugs in adult patients with partial seizures. Since this diagnostic category includes the largest number of patients with refractory epilepsy, new drugs with antiepileptic activity are usually tried first for this indication. Topiramate (toe pyre' a mate) is a structurally unique agent chemically related to the D-enantiomer of fructose.

The FDA has approved fidaxomicin (Dificid – Optimer), a new oral macrolide antibiotic, for treatment of Clostridium difficile-associated diarrhea in patients ≥18 years old. The incidence and severity of C. difficile infection (CDI) have increased in recent years with the emergence of an epidemic hypervirulent strain (NAP1/B1/027), possibly related to widespread use of fluoroquinolones.

Icosapent ethyl (Vascepa [vas EE puh] – Amarin), the ethyl ester of eicosapentaenoic acid (EPA), has been approved by the FDA as an adjunct to diet for treatment of severe hypertriglyceridemia (≥500 mg/dL). Vascepa is the second omega-3 polyunsaturated fatty acid (PUFA) product to become available by prescription for this indication; Lovaza (formerly Omacor), which is a combination of the ethyl esters of EPA and docosahexaenoic acid (DHA), was the first. Many omega-3 PUFA-containing fish oil capsules are sold over the counter as dietary supplements.

Eslicarbazepine acetate (Aptiom – Sunovion) has been approved by the FDA for adjunctive treatment of partial-onset seizures in adults. New drugs for epilepsy are often approved by the FDA initially only as adjunctive treatment for partial seizures. Eslicarbazepine acetate is a prodrug of eslicarbazepine, which is the S-isomer of the active metabolite of oxcarbazepine. Oxcarbazepine itself is similar to carbamazepine. Both oxcarbazepine and carbamazepine are available generically.

View the Comparison Table: Some Systemic Fluoroquinolones (online only)

The B-lymphocyte stimulator (BLyS)-specific inhibitor belimumab (Benlysta – GSK), which was approved earlier for treatment of active, autoantibody-positive, nonrenal, systemic lupus erythematosus (SLE), has now been approved for use in addition to standard therapy for treatment of active lupus nephritis in adults. Belimumab is the first drug to be approved in the US for treatment of both SLE and lupus nephritis.

The FDA has approved the fully-human programmed death ligand 1 (PD-L1) blocking antibody avelumab (Bavencio – EMD Serono/Pfizer) for treatment of metastatic Merkel cell carcinoma (MCC) in patients ≥12 years old. Avelumab is the first drug to be approved in the US for this rare skin cancer. About 1600 people in the US, most commonly older adults (mean age at presentation is 75 years), are diagnosed each year with MCC. Most of these patients can be treated with surgical resection, but ~50% will have a recurrence and >30% will eventually have metastatic disease. Median progression-free...

The immune checkpoint inhibitor pembrolizumab (Keytruda – Merck), a programmed death receptor-1 (PD-1) inhibitor, has been granted accelerated approval by the FDA for use in adults and children who have unresectable or metastatic microsatellite-instability-high (MSI-H) or mismatch-repair-deficient (dMMR) solid tumors that have progressed following treatment, and do not have any satisfactory alternative treatment options. For metastatic colorectal cancer, the indication is limited to tumors that have progressed following combination treatment with a fluoropyrimidine, oxaliplatin, and...

The FDA has approved Admelog (Sanofi-Aventis), an insulin lispro product similar to Humalog (Lilly), which went off patent in 2013.Approval of Admelog was based on efficacy data with Humalog and on two 6-month, open-label, randomized, noninferiority trials. In SORELLA 11 in 507 patients with type 1 diabetes and SORELLA 22 in 505 patients with type 2 diabetes, Admelog was noninferior to Humalog in lowering A1C, fasting plasma glucose levels, and self-monitored plasma glucose levels. The incidence of adverse effects, including hypoglycemia, was similar.Even though Admelog is very similar to...

The FDA has approved a new 550-mg tablet of rifaximin (Xifaxan – Salix), a minimally absorbed oral antibiotic, to reduce the risk of recurrent hepatic encephalopathy (HE). A 200-mg tablet has been available for treatment of travelers’ diarrhea since 2004.