The FDA has approved the proton-pump inhibitor (PPI) dexlansoprazole (Kapidex - Takeda), a delayed release formulation of the R-enantiomer of lansoprazole (Prevacid - Takeda), for treating and maintaining healing of erosive esophagitis and for treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD).

Dronedarone (Multaq - Sanofi-Aventis) has been approved by the FDA for oral treatment of atrial fibrillation and flutter. Amiodarone (Cordarone, and others) is the most effective drug for this indication, but has considerable toxicity.

The FDA has approved degarelix (Firmagon - Ferring), a synthetic decapeptide gonadotropin-releasing hormone (GnRH) receptor antagonist, for rapid medical castration of men with advanced prostate cancer. Abarelix (Plenaxis), the first GnRH antagonist approved by the FDA, was withdrawn from the US market because of immediate hypersensitivity reactions.

The FDA has approved the fluoroquinolone besifloxacin 0.6% ophthalmic suspension (Besivance - Bausch & Lomb) for treatment of bacterial conjunctivitis caused by susceptible bacteria. According to the manufacturer, this product was developed specifically for ophthalmic use in a specialized vehicle designed to prolong contact time on the ocular surface. Besifloxacin is not available for systemic use.

The FDA has approved Menveo (Novartis), a new quadrivalent conjugated polysaccharide vaccine, for protection against disease caused by Neisseria meningitidis in people 11-55 years old.

Colonoscopy remains the preferred method of colorectal cancer screening. Many patients consider cleansing the bowel in preparation for colonoscopy the most unpleasant part of the procedure, but inadequate bowel preparation significantly lowers the diagnostic yield.

The FDA has approved a fixed-dose combination of the long-acting anticholinergic glycopyrrolate and the long-acting beta2-adrenergic agonist (LABA) formoterol (Bevespi Aerosphere – AstraZeneca) for long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Glycopyrrolate/formoterol is the fourth long-acting anticholinergic/LABA combination to be approved in the US, but the first to become available in a metered-dose inhaler. Glycopyrrolate/indacaterol (Utibron Neohaler), umeclidinium/vilanterol (Anoro Ellipta), and tiotropium/olodaterol (Stiolto...

The FDA has approved Jornay PM (Ironshore), a capsule formulation of methylphenidate with a delayed-release outer layer and an extended-release inner layer, for once-nightly treatment of attention-deficit hyperactivity disorder (ADHD) in patients >6 years old. Jornay PM is the first methylphenidate product to become available in the US that is taken in the evening; other long-acting methylphenidate formulations are taken in the morning. It is being marketed specifically for patients who have disruptive ADHD symptoms in the morning.

The FDA has approved two new drugs for treatment of previously-treated unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer: fam-trastuzumab deruxtecannxki (Enhertu – Daiichi-Sankyo/AstraZeneca), an IV HER2-directed monoclonal antibody linked to the topoisomerase I inhibitor DXd, and tucatinib (Tukysa – Seagen), an oral tyrosine kinase inhibitor.

The FDA has approved mavacamten (Camzyos – MyoKardia/BMS), a modulator of cardiac myosin, to improve functional capacity and symptoms in adults with New York Heart Association (NYHA) class II or III obstructive hypertrophic cardiomyopathy (HCM) who have a baseline left ventricular ejection fraction (LVEF) ≥55%. Mavacamten is the first drug in its class to become available in the US.