On December 22, 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug nirmatrelvir copackaged with the HIV-1 protease inhibitor ritonavir (Paxlovid – Pfizer) for oral treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh at least 40 kg and are at high risk of progressing to severe disease, including hospitalization or death. Paxlovid was the first oral antiviral drug to be authorized in the US for treatment of COVID-19; Merck's oral antiviral drug molnupiravir was granted an EUA for treatment of COVID-19 on...

Alprazolam, a short-acting benzodiazepine, is one of the most widely prescribed drugs in the US. It is approved by the FDA for treatment of anxiety and panic disorder. An extended-release formulation, Xanax XR, which can be taken once a day, recently became available for panic disorder.

Paliperidone (Invega - Janssen) has been approved by the FDA in an extended-release formulation for treatment of schizophrenia. It is the primary active metabolite of the second-generation antipsychotic risperidone (Risperdal - Janssen), which is scheduled to lose its patent exclusivity in December 2007.

Finasteride (Proscar - Merck) has now been approved by the US Food and Drug Administration (FDA) for oral treatment of benign prostatic hyperplasia. A 4-aza-steroid, the drug is a specific inhibitor of steroid 5 -reductase, the enzyme that catalyzes conversion of testosterone to dihydrotestosterone. Dihydrotestosterone is required for development and maintenance of prostatic hypertrophy (JS Tenover, Endocrinol Metab Clin North Am, 20:893, 1991).

Minoxidil 2% topical solution (Rogaine - Upjohn) has been available in the USA since 1988 for treatment of androgenetic alopecia (Medical Letter, 29:87, 1987). Although available only by prescription, it is advertised on television to the general public.

Modafinil (Provigil), a benzhydryl sulfinylacetamide non-amphetamine stimulant that has been used in Europe since 1995, has now been approved by the FDA for treatment of excessive daytime sleepiness associated with narcolepsy.

The FDA has approved the nucleoside analog telbivudine (Tyzeka - Novartis/Idenix) for treatment of patients ≥16 years old with active chronic hepatitis B virus (HBV) infection. It is the fourth oral drug marketed for this indication in the US.

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide, previously approved by the FDA for treatment of type 2 diabetes as Victoza, has now also been approved at a higher dose as Saxenda (Novo Nordisk) for chronic weight management in adults with a BMI ≥30, or a BMI ≥27 with a weight-related comorbidity such as hypertension, dyslipidemia, or diabetes.

Dirithromycin (Dynabac - manufactured by Lilly, distributed by Bock), an oral macrolide antibiotic chemically similar to erythromycin, clarithromycin (Biaxin) and azithromycin (Zithromax), has been approved for marketing by the US Food and Drug Administration (FDA).

Tizanidine (Zanaflex - Athena Neurosciences) has been approved by the US Food and Drug Administration for oral treatment of increased muscle tone associated with spasticity. It has been available in Europe and Japan for 12 years as a short-term muscle relaxant.