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...

The FDA has approved a long-acting fixed-dose combination of the stimulant dexmethylphenidate and the prodrug serdexmethylphenidate (Azstarys – Corium) for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old. Azstarys is the first product containing serdexmethylphenidate to become available in the US.

The FDA has approved Seglentis (Esteve/Kowa), an oral combination of tramadol hydrochloride, a weak opioid agonist and weak serotonin and norepinephrine reuptake inhibitor (SNRI), and celecoxib, a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID), for use in adults with acute pain that is severe enough to require an opioid and for which alternative treatment options are inadequate.

An outbreak of monkeypox has recently spread around the globe and across the US. Updated information about the current outbreak is available from the CDC.

Pharmacologic management of opioid withdrawal symptoms can reduce the intensity of drug craving and improve treatment retention in patients with opioid use disorder who will receive maintenance treatment. Withdrawal management without subsequent maintenance treatment is associated with high rates of relapse, overdose death, and HIV and/or hepatitis C virus infection. Several guidelines on management of opioid withdrawal are available. Maintenance treatment of opioid use disorder was reviewed in a previous issue.