The FDA has approved Quartette (Teva), an extended-cycle combination oral contraceptive containing increasing doses of the estrogen ethinyl estradiol (EE) combined with the progestin levonorgestrel (LNG). The rationale is that a gradual increase in the EE dose may reduce unscheduled bleeding or spotting, a common adverse effect of extended-cycle oral contraceptives.

Aducanumab-avwa (Aduhelm – Biogen/Eisai), an IV amyloid beta-directed monoclonal antibody, has received accelerated approval from the FDA for treatment of Alzheimer's disease. The approval was based on the surrogate endpoint of reduction in amyloid beta plaques in the brain. The manufacturer is required to conduct an additional randomized controlled trial to establish that reducing amyloid beta plaques with aducanumab improves clinical outcomes in patients with Alzheimer's disease.

The FDA has approved a higher-dose injectable formulation of the opioid antagonist naloxone (Zimhi – Adamis) for emergency treatment of opioid overdose. A single IM or SC injection of the new formulation delivers 5 mg of naloxone; injectable formulations that deliver 0.4 mg or 2 mg of the drug have been available for years. Naloxone is also available in intranasal formulations for the same indication (see Table 1).

On April 29, the NIH recommended against use of the antiparasitic drug ivermectin for treatment of COVID-19 outside of a clinical trial. The recommendation was made because recent randomized, placebo-controlled trials of ivermectin have produced negative results and because alternative drugs that have been shown to be effective for treatment of COVID-19 are available.

The oral gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix (Orgovyx – Myovant Sciences/Pfizer) has been approved by the FDA for treatment of advanced prostate cancer in adults. It is the first oral GnRH receptor antagonist to become available in the US; degarelix (Firmagon), an injectable GnRH receptor antagonist, has been available since 2008 for the same indication.

Doxazosin (mesylate - Roerig), an alpha1-adrenergic receptor blocker similar to prazosin (Minipress, and others) and terazosin (Hytrin), was recently approved by the US Food and Drug Administration for treatment of hypertension.

An aqueous formulation of alprostadil (prostaglandin E 1 ; - Upjohn) has been approved by the US Food and Drug Administration (FDA) for injection into the corpus cavernosum to treat erectile dysfunction. The drug is also marketed as Prostin VR, an alcohol-containing formulation, for intravenous use in newborns with congenital heart disease to maintain the patency of the ductus arteriosus.

Tacrolimus ointment (Protopic) has been approved by the FDA in 0.03% and 0.1% formulations for treatment of atopic dermatitis. Tacrolimus is used systemically (Prograf) to prevent rejection of organ transplants.

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.).

Warfarin-related bleeding, especially intracranial hemorrhage, can be catastrophic. Several products are available to reverse warfarin’s anticoagulant effect.