The FDA has approved an estradiol softgel vaginal insert (Imvexxy – TherapeuticsMD) for treatment of postmenopausal women with moderate to severe dyspareunia due to vulvovaginal atrophy (VVA). Imvexxy is the second estradiol vaginal insert to be approved in the US; Vagifem, an intravaginal tablet formulation, was the first. Vagifem and Imvexxy are both available in inserts containing 10 mcg of estradiol; Imvexxy is also available in a 4-mcg strength.

The FDA has approved Cinvanti (Heron), an IV emulsion formulation of the substance P/neurokinin-1 (NK1) receptor antagonist aprepitant, for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in adults. Aprepitant is also available in oral capsule and suspension formulations (Emend, and generics), and fosaprepitant, a prodrug of aprepitant, is available in an IV formulation (Emend for injection).

The FDA has approved the complement C3 inhibitor pegcetacoplan (Syfovre – Apellis) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Given as a series of monthly or every-other-month (EOM) intravitreal injections, it is the first drug to become available for use in patients with atrophic dry AMD. Subcutaneous pegcetacoplan was approved earlier as Empaveli for treatment of paroxysmal nocturnal hemoglobinuria.

The FDA has approved the complement C5 inhibitor avacincaptad pegol (Izervay – Iveric) for intravitreal treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Avacincaptad pegol is the second complement inhibitor to be approved in the US for this indication; pegcetacoplan (Syfovre), a complement C3 and C3b inhibitor, was approved earlier.

The FDA has approved the dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin (Nesina – Takeda) for treatment of type 2 diabetes. In addition to the single-ingredient product, the FDA also approved fixed-dose combinations of alogliptin/metformin (Kazano) and alogliptin/pioglitazone (Oseni) for the same indication. Alogliptin is the fourth DPP-4 inhibitor to become available in the US. The other three – saxagliptin (Onglyza), sitagliptin (Januvia), and linagliptin (Tradjenta) – are also available in fixed-dose combinations with metformin.

Solifenacin succinate (VESIcare - Yamanouchi and GlaxoSmithKline) and darifenacin hydrobromide (Enablex - Novartis) have been approved by the FDA for oral treatment of overactive bladder.

Major orthopedic surgery creates a prothrombotic state by causing tissue injury during the operation and requiring relative immobilization during recovery. Without thromboprophylaxis, 40-60% of patients undergoing major knee or hip surgery develop venographically detectable deep vein thrombosis (DVT) and 1 in 300 undergoing total hip replacement will have a symptomatic pulmonary embolism (PE). Thromboprophylaxis reduces the incidence of venous thromboembolism (VTE), but it also can cause bleeding. New guidelines for prevention of VTE have recently been published.

The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has been approved by the FDA for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangements. It is the first targeted therapy to be approved in the US for this indication. The drug received accelerated approval from the FDA in 2020 for treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or other rearrangements.

Eszopiclone (Lunesta - Sepracor), a benzodiazepine-like drug, has been approved by the FDA for oral treatment of insomnia. It is the S-isomer of zopiclone (Imovane, and others in Canada), which has been available in other countries for almost 20 years. Unlike similar drugs such as zolpidem (Ambien) or zaleplon (Sonata), Lunesta is not being restricted in its labeling to short-term use. Like other hypnotics, eszopiclone is a schedule IV drug.

Aprepitant (Emend - Merck), the first substance P/neurokinin 1 (NK₁) receptor antagonist to be approved by the FDA, is now available for oral use with corticosteroids and selective serotonin (5-HT₃) receptor antagonists to prevent nausea and vomiting caused by highly emetogenic anticancer drugs such as cisplatin.