The oral sphingosine 1-phosphate (S1P) receptor modulator etrasimod (Velsipity – Pfizer) has been approved by the FDA for treatment of moderately to severely active ulcerative colitis in adults. It is the second oral S1P receptor modulator to be approved in the US for this indication; ozanimod (Zeposia) was the first.

The FDA has approved an oral extended-release formulation of gepirone (Exxua – Fabre-Kramer), a selective 5-HT_1A receptor agonist, for treatment of major depressive disorder (MDD) in adults. Gepirone was originally developed decades ago for treatment of anxiety and depression, but it was not approved by the FDA for such use. Gepirone is structurally related to buspirone, which is FDA-approved for treatment of anxiety.

In overactive bladder, involuntary bladder contractions due to detrusor overactivity result in urinary urgency, frequency, nocturia, and incontinence. The prevalence of the disorder increases with age. Nonpharmacologic treatment, including bladder training, urge suppression, pelvic floor muscle exercises, constipation management, modification of fluid intake, and avoidance of dietary irritants such as alcohol and caffeine, should be tried first.

The tables in this article list drugs used for treatment of cancer in the USA and Canada and their major adverse effects. The choice of drugs in Table I is based on the opinions of Medical Letter consultants. Some drugs are listed for indications for which they have not been approved by the US Food and Drug Administration. In some cases, such as elderly patients or those with many co-morbid illnesses, the regimen of choice might not be suitable. For many of the cancers listed, surgery and/or radiation therapy may be the treatment of choice or may also be part of the management. Anticancer...

BiDil (NitroMed), a fixed-dose combination of isosorbide dinitrate and hydralazine, was approved by the FDA for adjunctive use in the treatment of heart failure in black patients.Both drugs are oral vasodilators that have been used together off-label for many years to treat heart failure in patients not responding to other drugs.

Gamma hydroxybutyrate (GHB), a central-nervous-system depressant notorious for its use in "date rape", was approved by the FDA in 2002 as sodium oxybate (Xyrem - Jazz Pharmaceuticals) for oral treatment of cataplexy in patients with narcolepsy. Now it has also been approved for treatment of excessive daytime sleepiness (EDS) in these patients. Xyrem is a Schedule III controlled substance.

Conivaptan hydrochloride (Vaprisol - Astellas), a vasopressin antagonist, has been approved by the FDA for short-term intravenous (IV) treatment of euvolemic hyponatremia in hospitalized patients. Euvolemic hyponatremia is most often caused by the syndrome of inappropriate ADH secretion (SIADH), or by hypothyroidism or adrenal insufficiency. The drug has not been approved for treatment of hypervolemic hyponatremia, which is associated with congestive heart failure (CHF), cirrhosis and renal disease. It should not be used in hypovolemic hyponatremia, such as occurs when fluid losses are...

The FDA has approved the prostaglandin analog bimatoprost in a 0.03% solution (Latisse - Allergan) for increasing eyelash length, thickness and darkness in patients with hypotrichosis of the eyelashes.

The FDA has approved two new inhalers for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). Seebri Neohaler (Novartis) contains the long-acting anticholinergic glycopyrrolate. Utibron Neohaler (Novartis) contains both glycopyrrolate and the long-acting beta2-adrenergic agonist (LABA) indacaterol. Glycopyrrolate/indacaterol is the third fixed-dose combination of a long-acting anticholinergic and a LABA to become available in the US; umeclidinium/vilanterol (Anoro Ellipta) and tiotropium/olodaterol (Stiolto Respimat) were approved...

The FDA has approved brigatinib (Alunbrig – Takeda), an oral tyrosine kinase inhibitor, for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Xalkori). Translocations of the ALK gene are found in about 5% of lung cancers; they occur predominantly in nonsmokers with adenocarcinoma. Brigatinib is the third tyrosine kinase inhibitor to be approved for this indication; ceritinib (Zykadia) and alectinib (Alecensa) were approved earlier, and subsequently were...