Many drugs, mostly imidazole derivatives, are marketed in the USA for topical treatment of vulvovaginal candidiasis (Medical Letter, 33:81, 1991). Recently, fluconazole (Diflucan - Roerig), which is the drug of choice for treatment of oropharyngeal and esophageal candidiasis (Medical Letter, 36:16, 1994), was approved by the US Food and Drug Administration for single-dose oral treatment of .

The FDA has approved Twirla (Agile Therapeutics), a transdermal contraceptive patch containing the estrogen ethinyl estradiol and the progestin levonorgestrel, for use in women with a BMI <30 kg/m². It is the second contraceptive patch to become available in the US; Xulane, a patch that delivers ethinyl estradiol and the progestin norelgestromin, has been available since 2014.

The IV antiviral drug remdesivir (Veklury – Gilead) has been available for treatment of COVID-19 in hospitalized patients since 2020. Now, the FDA has approved remdesivir for treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh ≥40 kg and are at high risk for progression to severe disease, including hospitalization or death; they also issued an Emergency Use Authorization (EUA) allowing its use in any other high-risk outpatient who weighs ≥3.5 kg.

Teplizumab-mzwv (Tzield – Provention Bio), an anti-CD3 monoclonal antibody, has been approved by the FDA to delay the onset of stage 3 type 1 diabetes in patients ≥8 years old who have stage 2 type 1 diabetes. It is the first drug to become available in the US that delays the onset of type 1 diabetes.

Lisdexamfetamine dimesylate (Vyvanse), a prodrug of dextroamphetamine previously approved for treatment of attention-deficit/hyperactivity disorder, has now been approved for treatment of moderate-to-severe binge eating disorder (recurrent episodes of compulsive overeating without purging) in adults.FDA approval of lisdexamfetamine for this indication was based on two unpublished, 12-week trials, summarized in the package insert, that randomized patients with moderate-to-severe binge eating disorder to lisdexamfetamine 30 mg/day, which was titrated to 50 mg or, if needed, 70 mg, or to placebo....

In our article on Bijuva, the oral fixed-dose combination of estradiol and progesterone (Med Lett Drugs Ther 2019; 61:99), Table 1 should have included single-ingredient oral formulations of estradiol and progesterone (see below). They will be added to the table as it appears online, along with medroxyprogesterone (Provera, and generics), another single-ingredient progestin available for use in women with an intact uterus who take systemic estrogen for menopausal symptoms. Taking generic estradiol and progesterone separately may be less convenient than taking Bijuva, but they cost less and...

The FDA has approved istradefylline (Nourianz — Kyowa Kirin), an oral adenosine A_2A receptor antagonist, for use as an adjunct to carbidopa/levodopa in adults with Parkinson's disease (PD) who experience "off" episodes. Istradefylline is the first adenosine A_2A receptor antagonist to be approved in the US; it has been available in Japan since 2013.

Obinutuzumab (Gazyva – Genentech), a humanized anti-CD20 monoclonal antibody, has been approved by the FDA for use in combination with chlorambucil (Leukeran) in patients with previously untreated chronic lymphocytic leukemia (CLL). Two other anti-CD20 antibodies, rituximab (Rituxan) and ofatumumab (Arzerra), were previously approved for treatment of CLL.

View the Expanded Table: Statins

Abarelix (Plenaxis - Praecis Pharmaceuticals), an injectable gonadotropin-releasing hormone (GnRH) antagonist, has been approved by the FDA for treatment of advanced symptomatic prostate cancer in patients who should not take luteinizing hormone-releasing hormone (LHRH) agonists and who refuse treatment with surgical castration.