The FDA has approved an extended-release tablet formulation of amantadine (Osmolex ER – Vertical/Osmotica) for once-daily treatment of Parkinson's disease (PD) and drug-induced extrapyramidal symptoms (EPS) in adults. An extended-release capsule formulation of amantadine (Gocovri) was approved in 2017 for treatment of levodopa-induced dyskinesia in patients with PD.

Lecanemab-irmb (Leqembi – Biogen/Eisai), an IV amyloid beta-directed monoclonal antibody, has received accelerated approval from the FDA for treatment of Alzheimer's disease. The label states that treatment with Leqembi should be initiated in patients with mild cognitive impairment (MCI) or mild dementia, the population in which the drug was initiated in clinical trials. Lecanemab is the second IV amyloid-beta directed monoclonal antibody to be approved for this indication; aducanumab (Aduhelm) was approved in 2021 and has the same restrictions on treatment...

The oral kinase inhibitor capivasertib (Truqap – AstraZeneca), a first-in-class AKT inhibitor, has been approved by the FDA for use in combination with the selective estrogen receptor degrader (SERD) fulvestrant (Faslodex, and generics) for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults with one or more PIK3CA/AKT1/PTEN-alterations who had disease progression on at least one endocrine-based regimen for metastatic disease or recurrence on or within 12 months of completing...

The FDA has approved donislecel-jujn (Lantidra – CellTrans), an allogeneic pancreatic islet cellular therapy, for use in conjunction with immunosuppression for treatment of adults with type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Donislecel is the first cell-based treatment to be approved in the US for type 1 diabetes.

Concizumab (Alhemo – Novo Nordisk), a subcutaneously injected tissue factor pathway inhibitor (TFPI) antagonist, has been approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients ≥12 years old who have hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. It is the second TFPI antagonist to be approved in the US for treatment of hemophilia A or B; the TFPI antagonist marstacimab (Hympavzi) is approved for use in patients without inhibitors.

Acne is common among adolescents and adults. Guidelines for treatment of acne were last published by the American Academy of Dermatology in 2016.

Mitoxantrone (Novantrone - Lederle), a synthetic anthracene related to the anthracyclines doxorubicin (Adriamycin) and daunorubicin (Cerubidine), has now been marketed in the USA to be used in combination with other drugs for initial treatment of acute nonlymphocytic leukemia in adults.

Betaxolol (Kerlone - Searle), an oral beta-adrenergic blocker, was recently approved by the US Food and Drug Administration for once-daily treatment of hypertension. The new drug is beta 1 (cardio)-selective with no intrinsic sympathomimetic (partial agonist) activity. It is also available in a topical formulation for treatment of glaucoma (Betoptic - Medical Letter, 28:45, 1986). Beta-blockers currently available in the USA for treatment of hypertension are listed in the table below.

Lopinavir/ritonavir is the first fixed-dose combination of protease inhibitors approved by the FDA for the treatment of HIV infection. It is being marketed for use with other drugs in adults and children more than six months old. Lopinavir is a new drug available only in this combination. Ritonavir is often used with other protease inhibitors to raise their plasma concentrations.

Vardenafil (Levitra -Bayer) is the second oral drug approved by the FDA for treatment of erectile dysfunction. Sildenafil (Viagra - Medical Letter 1998; 40:51), the first oral drug, has been available for 5 years. Pharmacokinetics, effectiveness, adverse effects, dosage and cost of the new drug are reviewed. Whether it offers any benefits over sildenafil is discussed.