The FDA has approved talimogene laherparepvec (Imlygic – Amgen), a genetically modified herpes simplex virus, for intralesional treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma that has recurred following surgery. It is the first oncolytic virotherapy to become available in the US.

The FDA has approved a once-daily, extended-release chewable tablet formulation of methylphenidate (QuilliChew ER – Pfizer) for treatment of attention-deficit/hyperactivity disorder (ADHD). It is the first long-acting chewable formulation of the drug to be marketed in the US. Immediate-release chewable methylphenidate tablets (Methylin, and generics) have been available since 2003.

The FDA has approved ciprofloxacin 6% otic suspension (Otiprio – Otonomy) for single-dose prophylaxis in children with bilateral otitis media with effusion who are undergoing tympanostomy tube placement. It is the first drug to be approved for this indication in the US. Otic formulations of the fluoroquinolone antibiotics ofloxacin (Floxin Otic, and generics) and ciprofloxacin (plus dexamethasone; Ciprodex) have been available for years for treatment of acute otitis media in children with tympanostomy tubes; an otic suspension containing ciprofloxacin and fluocinolone...

The FDA has announced that it is requiring changes in the labeling of systemic fluoroquinolones to warn that the risk of serious adverse effects, including tendinitis, peripheral neuropathy and CNS effects, generally outweighs their benefit for the treatment of acute sinusitis, acute exacerbations of chronic bronchitis, and uncomplicated urinary tract infections. For these infections, the new labels will recommend reserving fluoroquinolones for patients with no other treatment options.

Eteplirsen (Exondys 51 – Sarepta), an antisense oligonucleotide, has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the dystrophin gene that is amenable to exon 51 skipping. It is the first drug to be approved for treatment of DMD.

With the widespread adoption of the CHA₂DS₂-VASc scoring system, oral anticoagulation therapy is now recommended for all patients ≥75 years old with nonvalvular atrial fibrillation. Atrial fibrillation has, however, been associated with an increased risk of falls, and older patients starting warfarin for atrial fibrillation have a high rate of hospitalization for intracranial bleeding. Many practitioners are reluctant, therefore, to prescribe an oral anticoagulant for elderly patients who are at high risk for falls.

The FDA has approved ferric pyrophosphate citrate solution (Triferic – Rockwell Medical) to maintain hemoglobin concentrations in adults with hemodialysis-dependent chronic kidney disease. Triferic is the first iron replacement product that is added into the hemodialysis solution at each dialysis procedure.

The results of the recently published FOURIER trial have shown a reduction in cardiovascular events with addition of the PCSK9 inhibitor evolocumab (Repatha) to statin therapy in patients with atherosclerotic cardiovascular disease (ASCVD).

The FDA has approved an effervescent tablet formulation of acetylcysteine (Cetylev – Arbor) to prevent or lessen hepatic injury after acetaminophen overdose. Acetylcysteine has been available for years in an IV solution (Acetadote, and generics) and an oral solution for the same indication; use of the oral solution has been limited by its unpleasant odor and taste.

The FDA has approved an extended-release intramuscular suspension formulation of the gonadotropin-releasing hormone (GnRH) agonist triptorelin (Triptodur – Arbor/Debiopharm) for twice-yearly treatment of central precocious puberty (CPP) in children ≥2 years old. Triptorelin has been available in the US for years as Trelstar for palliative treatment of advanced prostate cancer. Before the approval of Triptodur, Trelstar was used off-label for treatment of CPP.