The investigational oral antiviral drug molnupiravir (Merck/Ridgeback Biotherapeutics) was granted an FDA Emergency Use Authorization (EUA) on December 23, 2021 for treatment of mild to moderate COVID-19 in outpatients ≥18 years old who are at high risk of progressing to severe disease, including hospitalization or death (see Table 1), and for whom alternative treatment options are not available or clinically appropriate. Paxlovid (Pfizer), nirmatrelvir copackaged with ritonavir, was granted an EUA on December 22, 2021. The IV antiviral drug remdesivir (Veklury) was approved by the...

The RAS GTPase family inhibitor adagrasib (Krazati – BMS), which received accelerated approval for treatment of KRAS G12C (glycine-to-cysteine mutation at codon 12)-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in 2022, has now received accelerated approval from the FDA for use with cetuximab for treatment of KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC) in adults who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Adagrasib is the first KRAS inhibitor to be approved in the US for treatment...

Marstacimab-hncq (Hympavzi – Pfizer), a 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 without factor VIII inhibitors or hemophilia B without factor IX inhibitors. It is the first hemophilia treatment to be approved in the US that targets an inhibitor of coagulation and the first to become available in prefilled pens and syringes for subcutaneous administration.

View the Comparison Chart: Some Drugs for Irritable Bowel Syndrome with Diarrhea (IBS-D)

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.

The FDA has approved baloxavir marboxil (Xofluza – Shionogi/Genentech), the first polymerase acidic (PA) endonuclease inhibitor, for single-dose, oral treatment of acute uncomplicated influenza in patients ≥12 years old. Baloxavir is the first drug with a new mechanism of action to be approved for treatment of influenza in almost 20 years.

Fluoxetine (Prozac - Dista), a phenylpropylamide, is the first serotonin-reuptake blocker introduced in the USA for treatment of . It is being promoted as causing fewer adverse effects than other antidepressants. Claims of greater safety and patient tolerability have often been made for new non-tricyclic antidepressants in recent years, but unpredicted adverse effects have emerged with widespread use, including priapism with trazodone (Desyrel - Medical Letter, 26:35, 1984) and fatal hemolytic anemia with nomifensine (Merital - Medical Letter, 27:73, 1985).

In a study of the interaction between alcohol and the calcium-channel blocker felodipine (Plendil), the grapefruit juice vehicle for the alcohol appeared to increase felodipine plasma concentrations. Subsequent studies have found that grapefruit juice increases plasma concentrations of several calcium-channel blockers and of some other drugs as well (DG Bailey et al, Clin Pharmacokinet, 26:91, 1994).

Ceftibuten (Cedax - Schering), an oral cephalosporin similar to cefixime (Suprax - Medical Letter, 31:73, 1989), has been approved by the US Food and Drug Administration (FDA) for treatment of acute otitis media, pharyngitis or tonsillitis, and for acute bacterial exacerbations of chronic bronchitis.

The antiestrogen toremifene (Fareston - Schering) and the selective aromatase inhibitor letrozole (Femara - Novartis) have been approved by the FDA for treatment of advanced breast cancer in postmenopausal women.