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.

An injectable gel of hyaluronic acid (Restylane) has been approved by the FDA for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Manufactured by Q-Med AB, a Swedish company, it has been used outside the US since 1996.

The FDA has approved mepolizumab (Nucala - GSK), a subcutaneously injected humanized interleukin-5 (IL-5) antagonist monoclonal antibody, for maintenance treatment of severe asthma in patients ≥12 years old who have an eosinophilic phenotype.

The investigational monoclonal antibodies casirivimab and imdevimab (REGEN-COV – Regeneron) have been available in the US under an Emergency Use Authorization (EUA) since late 2020 for use together to treat mild to moderate COVID-19 in persons ≥12 years old who weigh ≥40 kg and are at high risk of progression to severe disease or hospitalization. The FDA has now expanded this EUA to allow use of the antibodies together for post-exposure prophylaxis of COVID-19 in such persons, if they are not fully vaccinated against COVID-19 or are unlikely to have an adequate immune response...

Balfaxar (Octapharma), a human plasma-derived four-factor prothrombin complex concentrate (PCC), has been approved by the FDA for rapid reversal of warfarin anticoagulation in adults who require an urgent surgical/invasive procedure. It is the second four-factor PCC to become available in the US; Kcentra, which has been available since 2013, is approved for the same indication and for urgent reversal of warfarin anticoagulation in adults with acute major bleeding. Balfaxar is marketed in Canada and Europe as Octaplex.

Lifileucel (Amtagvi – Iovance), a tumor-derived autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a mitogen-activated kinase (MEK) inhibitor. It is the first cellular therapy to be approved for use in solid tumors. Accelerated approval of lifileucel was based on objective response rates.

A Medical Letter reader asked about the use of the nutritional supplement 5-hydroxytryptophan (5-HTP) for treatment of depression. It is sold in health food stores, pharmacies and on-line for many indications including depression, mood enhancement, emotional well being, and promotion of normal sleep.5-HTP is the intermediate metabolite in the biosynthesis of serotonin from L-tryptophan.1 Many small studies in the 1970’s and 1980’s found 5-HTP helpful in the treatment of depression, but a Cochrane Review of 108 studies in patients with depression or dysthymia using 5-HTP or L-tryptophan...

A new epinephrine auto-injector is available in the US (Auvi-Q – Sanofi; Allerject in Canada) for emergency treatment of anaphylaxis. The new device is about the length and width of a credit card and as thick as a smartphone. It has a retractable needle system and a red safety guard located at the same end as the needle. Activation of the device by removing the outer case initiates an audio voice recording that provides step-by-step instructions and a 5-second countdown during the injection. The shelf-life of the epinephrine in the auto-injector is 18 months; the shelf-life of the battery is...

Femlyv (Millicent), an orally disintegrating tablet containing ethinyl estradiol and norethindrone acetate, has been approved by the FDA for prevention of pregnancy in females with a body mass index (BMI) ≤35 kg/m². It is the first hormonal contraceptive to become available in an orally disintegrating tablet formulation. Traditional oral and chewable tablets containing ethinyl estradiol and norethindrone acetate in a wide range of doses, including those found in Femlyv, have been available in the US for years.

Four different desk-top systems are now widely used in physicians'; offices to measure blood chemistries. The Ektachem DT (Kodak) and Reflotron (Boehringer Mannheim), reviewed previously in The Medical Letter (volume 30, page 119, 1988; volume 31, page 90, 1989), resemble the Seralyzer (Miles Diagnostics) in cost; the Vision (Abbott), which is fully automated, is much more expensive.