The FDA has approved the oral kinase inhibitor quizartinib (Vanflyta – Daiichi Sankyo) for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy in adults with FLT3 internal tandem duplication (ITD)-positive, newly-diagnosed acute myeloid leukemia (AML).

The FDA has approved Vowst (Seres Therapeutics/Nestle HealthScience), an oral capsule containing live fecal microbiota spores, for prevention of additional recurrences of Clostridioides difficile infection (CDI) in adults. Vowst is the first orally administered microbiota-based treatment to be approved for this indication. A rectally-administered live fecal microbiota-based suspension (Rebyota) was approved in 2022 for the same indication. Neither product is approved for acute treatment of CDI.

Ciprofloxacin hydrochloride (Cipro - Miles), a synthetic antibacterial agent, was recently marketed in the USA for oral treatment of a wide variety of infections. Ciprofloxacin is the second fluoroquinolone to become available in this country; norfloxacin (Noroxin - Medical Letter, 29:25, 1987) is marketed only for treatment of urinary tract infections. Fluoroquinolones are more potent and have a much broader spectrum of activity than older quinolones such as nalidixic acid (NegGram).

Ofloxacin (Floxin - McNeil, Ortho), a new fluoroquinolone antibacterial agent, was recently marketed in the USA for oral treatment of various infections caused by susceptible microorganisms. Ofloxacin is the third fluoroquinolone to become available in this country. Norfloxacin (Noroxin - Medical Letter, 29:25, 1987) is marketed only for treatment of urinary tract infections. Ciprofloxacin (Cipro - Medical Letter, 30:11, 1988), like ofloxacin, is approved for use in a variety of infections.

Enoxacin (en ox' a sin; Penetrex - Rh ne-Poulenc Rorer), a fluoroquinolone antimicrobial for oral use, has now been marketed in the USA for treatment of urinary tract infections and uncomplicated urethral or cervical gonorrhea.

Esomeprazole magnesium (Nexium - AstraZeneca), the S-isomer of omeprazole (Prilosec), is the fifth benzimidazole proton pump inhibitor to become available in the United States. Omeprazole, which was the first, is going off patent this year.

Oxaliplatin (Eloxatin -Sanofi-Synthelabo) has been approved by the FDA for use in combination with fluorouracil (5-FU; Adrucil, and others) and leucovorin (LV; Wellcovorin) for patients with metastatic colorectal cancer whose disease has recurred or progressed despite treatment with 5-FU/LV plus irinotecan (Camptosar - Medical Letter 1997; 39:8).

The FDA has approved romidepsin (Istodax – Celgene), an IV histone deacetylase (HDAC) inhibitor, for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The most common types of CTCL are mycosis fungoides, a low-grade lymphoma usually confined to the skin, and Sézary syndrome, a more aggressive disease with malignant lymphocytes in the blood. Both can progress to fatal systemic involvement. Romidepsin is the second HDAC inhibitor approved for this indication; vorinostat (Zolinza), an oral HDAC inhibitor, was approved...

The FDA has approved dolutegravir (doll-you-TEG-rah-veer; Tivicay – Viiv Healthcare), an integrase strand transfer inhibitor (INSTI), for treatment of HIV-1 infection in adults and in children ≥12 years old who weigh at least 40 kg. It is the third INSTI to be approved by the FDA; raltegravir and elvitegravir were approved earlier.

The antiplatelet drug clopidogrel (Plavix, and others) reduces major cardiovascular events, but can cause bleeding. Proton pump inhibitors (PPIs) are often used with clopidogrel to prevent gastrointestinal bleeding, however, some evidence suggests that PPIs may interfere with the activation of clopidogrel and diminish its antiplatelet effect. FDA-approved labeling recommends avoiding concurrent use of the PPIs omeprazole and esomeprazole with clopidogrel.