The FDA has approved Furoscix (scPharmaceuticals), a subcutaneous formulation of the loop diuretic furosemide administered via a single-use, on-body infusor, for treatment of congestion due to fluid overload in adults with New York Heart Association (NYHA) Class II-III chronic heart failure (HF). Furosemide (Lasix, and generics) has been available for years in oral and IV formulations.

Shock-wave generators like those now widely used to disintegrate urinary tract stones (Medical Letter, 27:72, 1985) have recently also been tried for treatment of radiolucent gallbladder stones. Three different types of lithotripsy devices, manufactured by at least eight different companies, are being used to treat gallbladder stones in multicenter trials in many locations in the USA. None of these devices has been approved for marketing by the US Food and Drug Administration.

There is no longer any doubt that an implantable cardioverter defibrillator (ICD) can reliably terminate most life-threatening ventricular tachyarrhythmias. The remaining question is who should get one. Guidelines prepared by an American College of Cardiology/American Heart Association task force have recently been published (G Gregoratos et al, Circulation 2002; 106:2145).

Testing for HIV infection in the US typically has been a two-step process that requires patients to return for results. This review describes two rapid tests currently FDA-approved, OraQuick and Reveal. It includes a table with the cost and characteristics of each test (result time, device type, equipment needed, etc.).

The FDA has approved Incruse Ellipta (GSK), a single-agent inhaler containing the long-acting anticholinergic umeclidinium, for once-daily maintenance treatment of chronic obstructive pulmonary disease (COPD). Umeclidinium was initially approved in combination with the long-acting beta₂-adrenergic agonist vilanterol as Anoro Ellipta.

The FDA has approved a sumatriptan iontophoretic transdermal system (Zecuity – Teva) for acute treatment of migraine in adults. Sumatriptan, the first of seven serotonin receptor antagonists (triptans) approved for this indication, is the most frequently prescribed migraine treatment in the US. It is also available in oral, intranasal, and injectable formulations.

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...

An inhaled, dry-powder formulation of rapid-acting human insulin (Exubera - Pfizer) has been approved by the FDA for treatment of adults with type 1 or type 2 diabetes.

Deep brain stimulation (DBS) is increasingly used to treat advanced Parkinson's disease (PD), but few controlled clinical trials have been published. New evidence from a large controlled study has recently become available.

The FDA has approved Phexxi (Evofem), a nonhormonal prescription-only vaginal gel containing lactic acid, citric acid, and potassium bitartrate, for prevention of pregnancy. The gel is intended for on-demand contraception; it is not effective when used after intercourse. It was previously approved for use as a vaginal lubricant (Amphora), but was never marketed.