The FDA has approved a rapidly disintegrating tablet formulation of the antiepileptic drug levetiracetam (Spritam – Aprecia) for adjunctive treatment of partialonset, myoclonic, and primary generalized tonicclonic seizures. Oral and intravenous formulations of levetiracetam (Keppra, and generics) have been available for years. Although approved by the FDA only as adjunctive therapy, levetiracetam is commonly used as monotherapy for partial-onset and generalized seizures and may also be effective in treating absence seizures and seizures of Lennox-Gastaut syndrome.

The FDA has approved Xtampza ER (Collegium), a new extended-release, abuse-deterrent capsule formulation of oxycodone, for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Two new extended-release amphetamine products have been approved by the FDA for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old: Adzenys XR-ODT (Neos Therapeutics), an orally distintegrating tablet, and Dyanavel XR (Tris Pharma), an oral suspension.

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 the atypical antipsychotic pimavanserin (Nuplazid – Acadia) for treatment of hallucinations and delusions associated with Parkinson's disease. It is the first drug to be approved in the US for this indication.

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.

Antimicrobial prophylaxis can decrease the incidence of postoperative surgical site infection after some procedures. Since the last Medical Letter article on this subject, consensus guidelines have been published. Recommendations for prophylaxis in specific surgical procedures are listed in Table 1.

The FDA recently approved ixazomib (Ninlaro – Takeda), daratumumab (Darzalex – Janssen Biotech), and elotuzumab (Empliciti – BMS) for treatment of relapsed and/or refractory multiple myeloma.

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...