Erdafitinib (Balversa – Janssen), an oral kinase inhibitor, has received full approval from the FDA for treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3 (fibroblast growth factor receptor) genetic alterations who had disease progression on or after at least one prior line of systemic therapy. It is not recommended for use in patients who are eligible for but have not received prior PD-1 (programmed death receptor-1) or PD-L1 (programmed death-ligand 1) inhibitor therapy. Erdafitinib is the first oral FGFR kinase inhibitor to be...

Obinutuzumab (Gazyva – Genentech), a CD20-directed monoclonal antibody, has been approved by the FDA for treatment of adults with active lupus nephritis who are receiving standard treatment. It was previously approved for treatment of chronic lymphocytic leukemia and follicular lymphoma. Obinutuzumab is the third drug to be approved in the US for treatment of lupus nephritis; the oral calcineurin inhibitor voclosporin (Lupkynis) and the parenteral B-lymphocyte stimulator (BlyS)-specific inhibitor belimumab (Benlysta) were approved earlier.

The gram-positive anaerobic bacillus Clostridium difficile is the most common identifiable cause of antibiotic-associated diarrhea. The antibiotics most often implicated have been ampicillin, second and third generation cephalosporins, clindamycin and fluoroquinolones. The emergence in recent years of a new, more toxic epidemic strain (BI/NAP1), possibly related to widespread use of fluoroquinolones, has caused a marked increase in the incidence and severity of C. difficile-associated disease (CDAD).

The FDA has approved deutetrabenazine (Austedo – Teva), a vesicular monoamine transporter 2 (VMAT2) inhibitor, for treatment of chorea associated with Huntington's disease and, more recently, for treatment of tardive dyskinesia in adults. It is the second VMAT2 inhibitor to be approved for each of these indications; tetrabenazine (Xenazine, and generics) was approved earlier for Huntington's chorea and valbenazine (Ingrezza) was recently approved for treatment of adults with tardive dyskinesia.

The FDA has approved Suflave (Sebela/Braintree), a low-volume polyethylene glycol (PEG)- and sulfate-based product for cleansing of the colon prior to colonoscopy in adults. Other oral colonoscopy preparations available in the US are listed in Table 2. Suflave is marketed as tasting better than other products.

Desmopressin acetate (DDAVP -Rorer), a synthetic analog of the natural human antidiuretic hormone arginine vasopressin, was recently approved by the US Food and Drug Administration for treatment of primary nocturnal enuresis. DDAVP Nasal Spray, which is similar to an intranasal solution that has been available in the USA for treatment of central diabetes insipidus (Medical Letter, 20:26, 1978), will be used for the new indication.

Strontium-89 chloride was recently approved for marketing by the US Food and Drug Administration. It is offered for relief of pain caused by metastatic bone lesions

Tamsulosin (Flomax - Boehringer Ingelheim), an alpha 1 - adrenoreceptor blocker, has been approved by the FDA for treatment of benign prostatic hyperplasia (BPH). It is claimed to bind preferentially to alpha1 receptors in the prostate.

The FDA has approved the opioid agonist hydromorphone in a once-daily extended-release (ER) oral tablet formulation (Exalgo – Covidien) for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, long-term therapy. Another hydromorphone ER formulation (Palladone – Purdue) was available previously, but was withdrawn from the market because taking it with alcohol could interfere with the extended-release mechanism and lead to rapid release of potentially lethal amounts of the drug ("dose-dumping").

The results of the AIM-HIGH trial conducted by the US National Heart, Lung and Blood Institute (NHLBI) were recently published. The goal of the trial was to test whether addition of niacin to intensive statin therapy would further reduce the risk of cardiovascular disease. The trial was stopped prematurely after an average follow-up of 3 years because niacin therapy had not shown any clinical benefit.