The FDA has approved the Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly) for oral treatment of adults with moderately to severely active rheumatoid arthritis (RA) that has not responded adequately to one or more tumor necrosis factor (TNF) inhibitors. Baricitinib is the second JAK inhibitor to be approved for treatment of RA; tofacitinib (Xeljanz, Xeljanz XR) was the first.

The FDA has approved lofexidine (Lucemyra – US WorldMeds/Salix), a centrally acting alpha₂ receptor agonist, to manage withdrawal symptoms in adults abruptly stopping opioid use. Available in the UK since 1992, lofexidine is the first nonopioid to be approved in the US for management of opioid withdrawal symptoms. Clonidine (Catapres, and generics), another central alpha₂ receptor agonist, has been used off-label for this indication for many years.

The FDA has approved two new ophthalmic drugs for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension: latanoprostene bunod (Vyzulta – Bausch and Lomb), a modified prostaglandin analog, and netarsudil (VRhopressa – Aerie), the first Rho kinase inhibitor to be approved in the US.

The FDA has approved vancomycin oral solution (Firvanq – Cutis Pharma) for treatment of Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (MRSA).

In our article on abuse-deterrent opioids (Med Lett Drugs Ther 2017; 59:95), the information on Targiniq ER in Table 1 is incorrect. The drug, which is not available in the US, is a combination of oxycodone ER and naloxone, not naltrexone, and naloxone is dispersed throughout the tablet, not sequestered. Targiniq ER will be deleted from the table in the article as it appears on our website.

The FDA has approved axicabtagene ciloleucel (Yescarta – Kite) for treatment of adults with relapsed or refractory CD19+ large B-cell lymphoma after ≥2 lines of systemic therapy. Yescarta is an individualized cellular product prepared from the patient's own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. It is the second CAR T-cell immunotherapy to become available in the US. Tisagenlecleucel (Kymriah), a CAR T-cell product previously approved for treatment of relapsed or refractory B-cell...

Apalutamide (Erleada – Janssen) has received accelerated approval from the FDA for treatment of nonmetastatic castration-resistant prostate cancer. It is the first drug to be approved in the US for this indication. Apalutamide is an oral antiandrogen that binds to the ligand-binding domain of the androgen receptor.

The FDA has approved erenumab-aooe (Aimovig – Amgen/Novartis), a once-monthly, subcutaneously-injected, monoclonal antibody against the calcitonin gene-related peptide receptor, for preventive treatment of migraine in adults. It is the first drug in its class to be approved by the FDA.

Coagulation factor Xa (recombinant), inactivated-zhzo (andexanet alfa; Andexxa – Portola) has received accelerated approval from the FDA for urgent reversal of the anticoagulant effect of the direct factor Xa inhibitors apixaban (Eliquis) and rivaroxaban (Xarelto). Andexanet alfa is the second antidote for a direct oral anticoagulant to become available in the US, and the fi rst for factor Xa inhibitors. Idarucizumab (Praxbind) was approved in 2015 for reversal of the anticoagulant effect of the direct thrombin inhibitor dabigatran etexilate (Pradaxa). Andexanet alfa has not...

The FDA has approved a fixed-dose combination of meropenem, a carbapenem antibiotic, and vaborbactam, a new beta-lactamase inhibitor (Vabomere – Melinta), for IV treatment of adults with complicated urinary tract infections (UTIs) that are proven or strongly suspected to be caused by Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae spp. complex. Meropenem (Merrem, and generics) has been approved for years for treatment of complicated skin and skin structure infections, intra-abdominal infections, and bacterial meningitis. Resistance to meropenem and other...