The FDA has approved a nasal spray formulation of fentanyl (Lazanda – Archimedes) for management of breakthrough pain in adult cancer patients who are already receiving and are tolerant to opioid therapy. Fentanyl is already available in the US for intravenous, intrathecal, epidural, transdermal and oral transmucosal use.

Inhaled antibiotics, which can achieve high concentrations in the lung with minimal systemic side effects, are probably the most effective therapy available for chronic Pseudomonas aeruginosa infection in patients with cystic fibrosis. An orally inhaled dry powder formulation of the aminoglycoside antibiotic tobramycin (Tobi Podhaler – Novartis) has been approved by the FDA for management of P. aeruginosa pulmonary infection in cystic fibrosis patients ≥6 years old. The new formulation is administered via a hand-held pocket-sized inhaler. Tobramycin is also available as an...

Obinutuzumab (Gazyva – Genentech), a humanized anti-CD20 monoclonal antibody, has been approved by the FDA for use in combination with chlorambucil (Leukeran) in patients with previously untreated chronic lymphocytic leukemia (CLL). Two other anti-CD20 antibodies, rituximab (Rituxan) and ofatumumab (Arzerra), were previously approved for treatment of CLL.

Quzyttir (TerSera), an IV formulation of the second-generation H1-antihistamine cetirizine, has been approved by the FDA for treatment of acute urticaria in patients ≥6 months old. Oral formulations of cetirizine (Zyrtec, and others) have been for sale over the counter for years. Quzyttir is the first parenteral formulation of a second-generation H1-antihistamine to become available in the US; parenteral formulations of two first-generation H1-antihistamines, diphenhydramine (Benadryl, and others) and hydroxyzine (Vistaril, and others), have been available for many...

The FDA has approved the oral kinase inhibitor encorafenib (Braftovi – Pfizer), in combination with the epidermal growth factor receptor (EGFR) inhibitor cetuximab (Erbitux), for treatment of adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. Encorafenib was approved in 2018 for use with the mitogen-activated kinase (MEK) inhibitor binimetinib (Mektovi) for treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance – Boehringer Ingelheim) has been approved by the FDA for a third indication: to reduce the risk of hospitalization for heart failure (HF) and cardiovascular death in patients with heart failure with reduced ejection fraction (HFrEF), with or without type 2 diabetes. The SGLT2 inhibitor dapagliflozin (Farxiga) was approved for the same indication in 2020. Empagliflozin has been granted breakthrough therapy designation for treatment of patients with heart failure with preserved ejection fraction...

On April 29, the NIH recommended against use of the antiparasitic drug ivermectin for treatment of COVID-19 outside of a clinical trial. The recommendation was made because recent randomized, placebo-controlled trials of ivermectin have produced negative results and because alternative drugs that have been shown to be effective for treatment of COVID-19 are available.

Meloxicam, a nonsteroidal anti-inflammatory drug (NSAID) with some cyclooxygenase-2 (COX-2) selectivity in vitro, has been approved by the FDA for treatment of osteoarthritis.

Insulin glulisine (Apidra - Sanofi Aventis) is the third rapid-acting insulin analog to be marketed in the US, following insulin lispro (Humalog) and insulin aspart (Novolog). All three have a more rapid onset and shorter duration of action than regular human insulin. Rapid-acting insulin analogs are generally taken immediately before meals and are usually combined with a long-acting basal insulin.

Sumatriptan was first marketed in the US in 1993 as Imitrex for subcutaneous injection, followed by tablets for oral administration and then by a nasal spray. It is one of seven serotonin receptor agonists (“triptans”) marketed in the US for treatment of migraine, but it is the only one available for subcutaneous injection. Now the FDA has approved Sumavel DosePro> (Zogenix), a needle-free device for delivering sumatriptan succinate to subcutaneous tissue, for treatment of migraine and cluster headache in adults.