On December 18, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Moderna mRNA-based vaccine for prevention of COVID-19 in persons ≥18 years old. The Pfizer-BioNTech mRNA-based vaccine received an FDA EUA for the same indication in persons ≥16 years old on December 11, 2020.

The FDA has approved the use of ambrisentan (Letairis) and tadalafil (Adcirca) together for treatment of pulmonary arterial hypertension (PAH). It is the first 2-drug regimen to be approved for this indication.

The FDA has approved voretigene neparvovec-rzyl intraocular suspension (Luxturna – Spark), an adeno-associated virus vector-based gene therapy, for treatment of confirmed biallelic RPE65 mutation-associated retinal dystrophy in patients who have viable retinal cells. It is the first gene replacement therapy approved in the US that targets a disease caused by mutations in a specific gene and the first pharmacologic treatment to be approved for this disorder.

The FDA has approved sodium zirconium cyclosilicate (Lokelma – AstraZeneca), an oral potassium binder that exchanges hydrogen and sodium for potassium in the gastrointestinal (GI) lumen, for treatment of non-life-threatening hyperkalemia in adults. Sodium zirconium cyclosilicate (SZC) is the third drug to be approved for this indication; sodium polystyrene sulfonate and patiromer (Veltassa) were approved earlier.

The FDA has licensed MenQuadfi (Sanofi Pasteur), a quadrivalent polysaccharide conjugate vaccine that uses tetanus toxoid as a protein carrier, for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y (MenACWY) in persons ≥2 years old.

Acne is common among adolescents and adults. Guidelines for treatment of acne were last published by the American Academy of Dermatology in 2016.

Dapagliflozin (dap" a gli fl oe' zin; Farxiga – Bristol-Myers Squibb/AstraZeneca), an SGLT2 (sodium-glucose co-transporter 2) inhibitor, has been approved by the FDA for oral treatment of type 2 diabetes. Dapagliflozin is the second SGLT2 inhibitor to be approved for this indication; canagliflozin (Invokana) was the first .

The FDA has approved the oral, once-daily, second-generation antipsychotic brexpiprazole (Rexulti – Otsuka/Lundbeck) for treatment of schizophrenia and as an adjunct to antidepressants for treatment of major depressive disorder (MDD). Aripiprazole (Abilify), a structurally similar second-generation antipsychotic also comarketed by Otsuka (with BMS), recently became available generically.

Antiretroviral therapy is recommended for all HIV-infected patients, both to reduce the risk of disease progression and to prevent transmission of the virus to others. Various guidelines for treatment of HIV infection are available.

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 .