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...

View the Expanded Table: Drugs for Prophylaxis of Malaria

Tofersen (Qalsody – Biogen), an intrathecally administered antisense oligonucleotide, has received accelerated approval from the FDA for treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. About 2% of patients with ALS have mutations in the SOD1 gene. Tofersen is the first drug to be approved in the US that targets a genetic cause of ALS. Accelerated approval of the drug was based on the surrogate endpoint of a reduction in plasma neurofilament light chain, which is considered likely to predict clinical...

Omalizumab (Xolair – Genentech), a recombinant anti-IgE monoclonal antibody FDA-approved for treatment of allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic urticaria, has now also been approved for use in conjunction with food allergen avoidance to reduce IgE-mediated food allergic reactions caused by accidental exposure in patients ≥1 year old. Omalizumab is the first drug to be approved in the US to reduce allergic reactions to more than one food. Palforzia, an oral peanut allergen powder, was approved in 2020 to mitigate allergic reactions caused by...

View the Comparison Table: Some Nonopioid Analgesics for Pain

Tafasitamab-cxix (Monjuvi – Morphosys), a CD19-directed cytolytic antibody, has received accelerated approval from the FDA for use in combination with lenalidomide (Revlimid) for treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from low grade lymphoma, in adults who are not eligible for autologous stem cell transplant. Accelerated approval was based on overall response rates.

The FDA has approved the oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq – Abbvie) for treatment of moderately to severely active ulcerative colitis in adults who have had an inadequate response to or cannot tolerate one or more tumor necrosis factor (TNF) inhibitors. Upadacitinib is the second JAK inhibitor to be approved for this indication; tofacitinib (Xeljanz) was the first. Upadacitinib is also approved for treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis.

The FDA has approved two new oral formulations of testosterone undecanoate — Kyzatrex (Marius) and Tlando (Antares) — for treatment of males with a deficiency of endogenous testosterone due to conditions such as Klinefelter syndrome, orchiectomy, toxic damage from chemotherapy or alcohol, or pituitary-hypothalamic injury caused by tumors, trauma, or radiation. Jatenzo, another oral testosterone undecanoate formulation, was approved for the same indication in 2019. No testosterone products are approved for treatment of low testosterone levels due solely to...

The FDA has approved an extended-release fixed-dose combination of dextromethorphan and bupropion (Auvelity – Axsome) for treatment of major depressive disorder (MDD) in adults.

The FDA has required the addition of information about an increased risk of nonmelanoma skin cancer (basal cell carcinoma [BCC] and squamous cell carcinoma [SCC]) to the labels of products containing the diuretic hydrochlorothiazide.