Radicava ORS, an oral suspension formulation of the free radical scavenger edaravone (Mitsubishi Tanabe Pharma), has been approved by the FDA for treatment of amyotrophic lateral sclerosis (ALS). An IV formulation of edaravone (Radicava) has been available since 2017.

Two new topical corticosteroids - fluticasone (Cutivate - Glaxo), a mediumpotency product, and halobetasol propionate (Ultravate - Westwood-Squibb), a superhigh- potency drug- were recently approved for marketing by the US Food and Drug Administration.

Gabapentin (Neurontin - Pfizer), which has been available in the US since 1994, is approved by the FDA only for treatment of partial epilepsy and postherpetic neuralgia, but is widely used off-label for a number of other indications, especially neuropathic pain syndromes. According to one report, among Medicaid recipients in Florida receiving gabapentin, 71% of prescriptions were for chronic pain and 8% for seizures and neuralgia ("The Pink Sheet" February 2, 2004; 66:30).

Gemifloxacin (Factive - Oscient), a new oral fluoroquinolone antibiotic, has been approved by the FDA for 5 days' treatment of acute bacterial exacerbations of chronic bronchitis (ABECB) and 7 days' treatment of mild to moderate community-acquired pneumonia (CAP) in adults. For the next 6-8 months it will only be available, presumably for commercial reasons, in states east of the Rocky Mountains.

Three new combination oral contraceptives (COCs) with shortened hormone-free intervals, Seasonique, Loestrin 24 Fe and Yaz, have recently been approved by the FDA. All 3 are derivatives of older products.

Direct-to-consumer advertisements are urging women to be tested for mutations in BRCA1 and BRCA2 genes, which are the most common known causes of an inherited predisposition to breast and ovarian cancer. Clinically important BRCA mutations have been found in about 2% of Ashkenazi Jewish women, and are estimated to occur in about 1 in 300 to 500 women in the general non-Jewish US population. The prevalence appears to be lower in non-whites.

Aliskiren (Tekturna - Novartis), the first direct renin inhibitor for treatment of hypertension, has been approved for use in a fixed-dose combination with the diuretic hydrochlorothiazide (Tekturna HCT - Novartis). Many angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) are also available in fixed-dose combinations with hydrochlorothiazide (HCTZ).

The FDA has approved benzyl alcohol lotion, 5% (Ulesfia Lotion - Sciele) for treatment of head lice in patients ≥6 months old. The active ingredient is 5% benzyl alcohol; the vehicle is 5% mineral oil.

The FDA has approved ivabradine (Corlanor – Amgen) to reduce the risk of hospitalization for worsening heart failure in adults with stable, symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≤35% who are in sinus rhythm with a resting heart rate ≥70 beats per minute and who are on maximum tolerated doses of beta blockers or have a contraindication to beta blocker use. Ivabradine has been available internationally for years as Procoralan and Corlentor for treatment of stable angina and heart failure.

The FDA has approved Xultophy 100/3.6 (Novo Nordisk), a fixed-ratio combination of insulin degludec and the GLP-1 (glucagon-like peptide-1) receptor agonist liraglutide, for once-daily treatment of adults with type 2 diabetes inadequately controlled on basal insulin (<50 units daily) or liraglutide (≤1.8 mg daily).