Belbuca (Endo), a buccal formulation of the partial opioid agonist buprenorphine, has been approved by the FDA for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. Buprenorphine is also available as a transdermal patch (Butrans) and in a parenteral formulation (Buprenex, and generics) for treatment of pain. A sublingual formulation of buprenorphine and buccal and sublingual formulations containing buprenorphine and the opioid antagonist naloxone are approved for use as alternatives to methadone for treatment of opioid...

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 Onzetra Xsail (Avanir), a nasal powder formulation of sumatriptan, for acute treatment of migraine in adults. Nasal spray formulations of sumatriptan (Imitrex) and zolmitriptan (Zomig) have been available for many years.

The FDA has approved Otovel (Arbor), a combination of the fluoroquinolone antibiotic ciprofloxacin 0.3% and the corticosteroid fluocinolone acetonide 0.025%, for otic treatment of acute otitis media with tympanostomy tubes (AOMT) in children ≥6 months old. It is the second fluoroquinolone/corticosteroid combination to be approved for this indication; ciprofloxacin 0.3%/dexamethasone 0.1% (Ciprodex) has been available for many years. In December 2015, a suspension of ciprofloxacin 6% (Otiprio) was approved for otic treatment of bilateral otitis media with effusion in children...

The FDA has approved the immune checkpoint inhibitor pembrolizumab (Keytruda – Merck), a programmed death receptor-1 (PD-1) inhibitor, for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) that highly expresses programmed death-ligand 1 (PD-L1) and has no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) translocations. About 25% of patients with advanced NSCLC have tumors with high levels of PD-L1 expression (PD-L1 expressed on ≥50% of tumor cells). Pembrolizumab was approved earlier for treatment...

The FDA has approved Kyleena (Bayer), an intrauterine device (IUD) that releases the synthetic progestin levonorgestrel, for prevention of pregnancy. It is the fourth levonorgestrel-releasing IUD to be approved in the US. Like Mirena, which has been available since 2000, Kyleena is approved for up to 5 years of use.

The FDA has approved the fully human monoclonal antibody bezlotoxumab (Zinplava – Merck) for use with antibacterial drug treatment to reduce recurrence of Clostridium difficile infection (CDI) in adults with CDI at high risk for recurrence. It is the first drug to be approved for this indication.

The FDA has approved the interleukin (IL)-23 blocker guselkumab (Tremfya – Janssen) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Guselkumab is the first selective IL-23 blocker to become available in the US.

The FDA has approved vericiguat (Verquvo – Merck), an oral soluble guanylate cyclase (sGC) stimulator, to reduce the risk of hospitalization for heart failure and cardiovascular (CV) death following a worsening heart failure event (hospitalization for heart failure or treatment with IV diuretics as an outpatient) in patients with symptomatic chronic heart failure and left ventricular ejection fraction (LVEF) <45%. Vericiguat is the second sGC stimulator to be marketed in the US. Riociguat (Adempas), which is FDA-approved for treatment of pulmonary arterial hypertension...

The FDA has approved evinacumab-dgnb (Evkeeza – Regeneron), an angiopoietin-like 3 (ANGPTL3) inhibitor, for adjunctive IV treatment of homozygous familial hypercholesterolemia (HoFH) in patients ≥12 years old. Evinacumab is the first ANGPTL3 inhibitor to be approved in the US.