On April 23, 2021, on advice from the Advisory Committee on Immunization Practices (ACIP), the FDA and CDC recommended that use of the Johnson & Johnson adenovirus-based COVID-19 vaccine resume despite its association with development of thrombosis with thrombocytopenia syndrome (TTS). Administration of the vaccine had been paused on April 13 because of 6 reports of TTS, but after completing a data review that identified a further 9 cases associated with the formulation, the agencies concluded that the benefits of the vaccine outweighed its risks. About 7.98 million doses of the...

The FDA has approved the over-the-counter (OTC) sale of Narcan (Emergent), a nasal spray that delivers 4 mg of the opioid antagonist naloxone. Narcan nasal spray has been available by prescription since 2015 for emergency treatment of opioid overdose. Generic formulations of Narcan have also been approved; the manufacturers of these products will be required to switch them to OTC status and amend their labeling accordingly. Kloxxado, an 8-mg naloxone nasal spray, remains available only by prescription.

The FDA has approved ustekinumab-auub (Wezlana – Amgen), an interchangeable biosimilar product similar to the interleukin-12 and -23 antagonist Stelara, for treatment of the same indications as Stelara (see Table 1). Wezlana is the first Stelara biosimilar to be approved in the US.

Revakinagene taroretcel-lwey (Encelto – Neurotech), an intravitreal allogeneic cell-based gene therapy, has been approved by the FDA for treatment of idiopathic macular telangiectasia type 2 in adults. It is the first treatment to be approved in the US for this indication.

Most respiratory tract infections are caused by viruses. Bacterial respiratory tract infections are usually treated empirically with antibiotic therapy that targets the most probable causative pathogens. Recommended antibiotic regimens for outpatient treatment of some common respiratory tract infections are listed in Table 1 for adults and Table 2 for children.

Pharmacologic management of chronic heart failure (HF) is primarily determined by the patient's left ventricular ejection fraction (LVEF) and severity of symptoms. Patients with chronic HF who have an LVEF ≤40% are considered to have heart failure with reduced ejection fraction (HFrEF) and those with an LVEF ≥50% are considered to have heart failure with preserved ejection fraction (HFpEF). Patients with an LVEF of 41-49% have heart failure with mildly reduced or mid-range ejection fraction.

The FDA has approved the proton pump inhibitor (PPI) esomeprazole strontium for use in adults for the same indications as esomeprazole magnesium (Nexium): treatment of gastroesophageal reflux disease (GERD), prevention of NSAID-induced gastric ulcers, eradication of Helicobacter pylori, and treatment of pathological hypersecretory conditions. It was first marketed in December 2013 as a branded drug (Esomeprazole Strontium) and a month later as a generic drug.Strontium is incorporated into bone. It is not recommended for use in children or during pregnancy because of the absence of safety data...

After our article on nivolumab (Opdivo – BMS) for treatment of metastatic melanoma and metastatic squamous non-small cell lung cancer (NSCLC) was published in the most recent issue of The Medical Letter (June 8, 2015),1 some new data became available supporting the efficacy of the drug in previously untreated melanoma and previously treated nonsquamous NSCLC.MELANOMA – In a double-blind trial, 945 patients with previously untreated, unresectable stage III or IV melanoma were randomized to receive ipilimumab, nivolumab, or combination therapy with ipilimumab and nivolumab. Progression-free...

The FDA has expanded its Emergency Use Authorizations (EUAs) for the COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of the bivalent formulations of these products (containing mRNA from the original and BA.4/5 Omicron strains of SARS-CoV-2) in children as young as 6 months. The bivalent Pfizer vaccine is authorized for use as the final dose of a 3-dose primary series in children 6 months to 4 years old. The bivalent Moderna vaccine is authorized for use as a booster dose in children 6 months to 5 years old who completed a primary...

Nadofaragene firadenovec-vncg (Adstiladrin – Ferring), an adenoviral vector-based gene therapy, has been approved by the FDA for treatment of adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. It is the first adenoviral vector-based gene therapy to be approved in the US for this indication. The immune checkpoint inhibitor pembrolizumab (Keytruda) was approved for the same indication in 2021.