Linaclotide (lin´´ a kloe´ tide; Linzess – Ironwood/Forest), a guanylate cyclase-C receptor agonist, was recently approved by the FDA for oral treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) in adults. It is the second drug approved for this indication; lubiprostone (Amitiza), a metabolite of prostaglandin E1, was the first.

A transdermal formulation of the second-generation (atypical) antipsychotic asenapine (Secuado – Noven) has been approved by the FDA for once-daily treatment of schizophrenia in adults. Asenapine is the first antipsychotic to become available in a transdermal formulation in the US. A twice-daily sublingual tablet formulation of asenapine (Saphris) has been available since 2009.

The FDA has issued an Emergency Use Authorization (EUA) for the long-acting investigational IV monoclonal antibody pemivibart (Pemgarda – Invivyd) for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old (weight ≥40 kg) who have moderate to severe immune compromise and are unlikely to respond adequately to COVID-19 vaccination (see Table 1). Pemgarda is the only drug that is currently authorized in the US for pre-exposure prophylaxis of COVID-19. Tixagevimab/cilgavimab (Evusheld) was previously available under an EUA for this indication, but it lacks activity against...

The FDA has approved changes to the labeling of Sublocade (Indivior), an extended-release formulation of the partial opioid agonist buprenorphine, to permit faster initiation and use of alternative injection sites. Sublocade is indicated for once-monthly subcutaneous treatment of moderate to severe opioid use disorder.

Two recombinant vaccines, Arexvy (GSK) and Abrysvo (Pfizer), have been approved by the FDA for prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults ≥60 years old. They are the first RSV vaccines to be approved in the US. Abrysvo is also approved for use in pregnant women at 32-36 weeks' gestation to prevent LRTD caused by RSV in their infants from birth through 6 months of age.

The FDA has approved two new drugs for treatment of adults with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria. Dalbavancin (Dalvance – Durata) is a long-acting intravenous (IV) lipoglycopeptide antibiotic similar to telavancin (Vibativ). Tedizolid phosphate (Sivextro – Cubist) is an IV and oral oxazolidinone antibacterial drug similar to linezolid (Zyvox). A third IV antibiotic, oritavancin (Orbactiv), recently approved by the FDA for the same indication, will be reviewed in a future...

The FDA has expanded its Emergency Use Authorization for the mRNA COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to include administration of a booster dose in children 5-11 years old who completed a primary series of the Pfizer vaccine ≥5 months previously.

Overweight is generally defined as a body mass index (BMI) between 25 and 29.9 kg/m2 in adults. A BMI ≥30 is considered obese (criteria differ slightly in Asian patients). In patients with an elevated BMI, a 5-10% reduction in weight has been associated with a reduction in the risk of developing type 2 diabetes, hypertension, and dyslipidemia. Diet, exercise, and behavior modification are the traditional methods for losing weight, but they are often inadequate; the American College of Cardiology no longer recommends that all patients try lifestyle modification alone before adding...

Self-injection of papaverine, a smooth muscle relaxant, and phentolamine (Regitine), an alpha-adrenergic blocker, directly into the corpus cavernosum has been effective for treatment of impotence in some patients, even after complete quadriplegia, radical surgery for bladder or prostate cancer, or castration (Medical Letter, 29:95, 1987). Recently, injections of prostaglandin E1, now called alprostadil (Prostin VR - Upjohn), have also been tried for this purpose. No drug is approved for this use by the US Food and Drug Administration.

Loratadine (Claritin - Schering), a new H 1 -receptor antagonist, has been approved by the U.S. Food and Drug Administration for treatment of seasonal allergic rhinitis in patients more than 12 years old. It will compete with older, relatively sedating drugs such as chlorpheniramine (Chlor-Trimeton, and others) and clemastine (Tavist - Medical Letter, 35:9, 1993) and with newer relatively non-sedating agents such as terfenadine (Seldane) and astemizole (Hismanal).