The FDA has approved the marketing of fingolimod (Gilenya – Novartis) to reduce the frequency of clinical exacerbations and delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis (MS). Fingolimod is the first oral drug approved for this indication.

The FDA recently approved the marketing of hydroxyprogesterone caproate injection (Makena – Ther-Rx) for prevention of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

The FDA has approved ingenol mebutate (Picato – Leo) for topical treatment of actinic keratoses (AKs). The new drug is derived from the sap of the Euphorbia peplus plant, a traditional folk remedy for warts and other skin lesions.

The FDA has approved a once-daily, extended-release oral suspension of methylphenidate (Quillivant XR – Pfizer) for treatment of attention-deficit/hyperactivity disorder (ADHD). It is the first liquid formulation of the drug to be marketed for once-daily use. A short-acting oral solution (Methylin, and generics) has been available since 2003.

The FDA has approved pomalidomide (Pomalyst – Celgene), an oral thalidomide analog, for treatment of patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide (Revlimid) and bortezomib (Velcade) and whose disease had progressed on or within 60 days of completion of the last therapy.

The FDA has approved idelalisib (Zydelig – Gilead), an oral kinase inhibitor, for use in combination with rituximab (Rituxan) for treatment of relapsed chronic lymphocytic leukemia (CLL). It is also approved as monotherapy for treatment of relapsed follicular lymphoma and relapsed small lymphocytic lymphoma (both are subtypes of indolent non-Hodgkins lymphoma) in patients who have received at least two prior systemic therapies.

The FDA has approved reslizumab (Cinqair – Teva), a humanized interleukin-5 (IL-5) antagonist monoclonal antibody, for add-on maintenance treatment of severe asthma in adults who have an eosinophilic phenotype. It is the second IL-5 antagonist to be approved in the US; mepolizumab (Nucala) was approved for the same indication in 2015.

The FDA has approved sugammadex (Bridion – Merck), a selective relaxant binding agent, for reversal of rocuronium- or vecuronium-induced neuromuscular blockade in adult surgical patients. It is the first selective relaxant binding agent to be approved in the US. Sugammadex has been available in the European Union, Japan, and elsewhere for several years. Previous FDA reviews of sugammadex did not result in approval because of concerns about a risk of anaphylaxis and other hypersensitivity reactions with its use.

The FDA has approved the selective alpha_1A-adrenergic receptor agonist oxymetazoline as a 1% cream (Rhofade – Allergan) for topical treatment of persistent facial erythema of rosacea in adults. Brimonidine, a selective alpha₂-adrenergic receptor agonist, was approved in 2013 as a 0.33% gel (Mirvaso) for the same indication. Like Mirvaso, Rhofade is not indicated for treatment of inflammatory lesions of rosacea. Oxymetazoline has been available over the counter for many years as a nasal decongestant spray (Afrin, and others).

View the Expanded Table: Drugs for Prophylaxis of Malaria