The FDA has approved a sublingual spray formulation of fentanyl (Subsys – Insys) for management of breakthrough pain in adult cancer patients who are receiving and are tolerant to opioid therapy (taking ≥60 mg/day of oral morphine or the equivalent). Fentanyl is already available in the US for intravenous, intrathecal, epidural, transdermal and transmucosal use.

A combination of the corticosteroid mometasone furoate (Asmanex) and the long-acting beta₂-agonist (LABA) formoterol (Foradil) has become available in a single metered-dose inhaler (Dulera – Schering) for treatment of asthma in patients ≥12 years old. It is the third corticosteroid/LABA combination inhaler to become available for this indication in the US. None of these combinations should be used for initial treatment of asthma or for acute treatment of asthma symptoms.

The FDA has approved lesinurad (Zurampic – Ironwood), a uric acid transporter 1 (URAT1) inhibitor, for adjunctive treatment of gout-associated hyperuricemia in patients whose serum uric acid levels fail to reach goal with xanthine oxidase inhibitor monotherapy.

The FDA has approved viloxazine extended-release capsules (Qelbree – Supernus) for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-17 years old. Viloxazine is the second selective norepinephrine reuptake inhibitor to be approved in the US for treatment of ADHD; atomoxetine (Strattera, and generics) was approved in 2002.

The FDA has approved istradefylline (Nourianz — Kyowa Kirin), an oral adenosine A_2A receptor antagonist, for use as an adjunct to carbidopa/levodopa in adults with Parkinson's disease (PD) who experience "off" episodes. Istradefylline is the first adenosine A_2A receptor antagonist to be approved in the US; it has been available in Japan since 2013.

View the Comparison Table: Inhaled Drugs for Treatment of COPD

S-adenosyl-methionine (SAM; SAMe; ademetionine; adomet), an endogenous compound synthesized from methionine and adenosine-triphosphate (ATP), has been marketed in stores and on the internet as a dietary supplement to promote "emotional well being."

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.

Trovafloxacin (Trovan - Pfizer) and its prodrug alatrofoxacin (Trovan IV) are new fluroroquinolones marketed for an unusually wide variety of infections, including oral and intravenous treatment of nosocomial and community-acquired pneumonia, acute ecerbations of chronic bronchitis, acute sinusitis, complicate intra-abdominal and pelvic infections, diabetic foot infection, uncomplicated urinary tract infection, prostatitis, cervicitis and uncomplicated gonorrhea.

The FDA has approved the hedgehog pathway inhibitor sonidegib (Odomzo – Novartis) for oral treatment of locally advanced basal cell carcinoma that cannot be treated with surgery or radiation or has recurred following such treatment. Vismodegib (Erivedge), another oral hedgehog pathway inhibitor, was approved earlier for the same indication and also for treatment of metastatic basal cell carcinoma.