Ixabepilone (ix ab ep' i lone; Ixempra - Bristol-Myers Squibb), a semisynthetic epothilone analog, has been approved by the FDA for treatment of advanced breast cancer. It is indicated for use in combination with capecitabine (Xeloda - Roche) for treatment of locally advanced or metastatic breast cancer after failure of an anthracycline such as doxorubicin (Adriamycin) and a taxane such as paclitaxel (Taxol, and others). It is also approved as monotherapy for treatment of metastatic or locally advanced breast cancer after an anthracycline, a taxane and capecitabine have...

The FDA has approved the marketing of sinecatechins (Veregen - Bradley/Medigene), a botanical drug product, for treatment of external genital and perianal warts. Sinecatechins is a water extract of green tea leaves from Camellia sinensis. It is a mixture of catechins and other green tea components.

Bendamustine HCl (Treanda - Cephalon), an unusual DNA-alkylating agent that has been used in Europe for many years to treat lymphoma, has now been approved by the FDA for treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).

The FDA has approved a long-acting fixed-dose combination of the stimulant dexmethylphenidate and the prodrug serdexmethylphenidate (Azstarys – Corium) for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old. Azstarys is the first product containing serdexmethylphenidate to become available in the US.

Elafibranor (Iqirvo – Ipsen), a peroxisome proliferator-activated receptor (PPAR) agonist, has been granted accelerated approval by the FDA for treatment of primary biliary cholangitis (PBC) in adults. It is indicated for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso, and others) in patients with an inadequate response to UDCA alone and as monotherapy in those unable to tolerate UDCA.

TThe FDA has licensed mResvia (Moderna), an mRNA respiratory syncytial virus (RSV) vaccine, for prevention of lower respiratory tract disease (LRTD) caused by RSV in adults ≥60 years old. It is the first mRNA vaccine to be licensed in the US for this indication. Two recombinant RSV vaccines, Arexvy and Abrysvo, are also available for prevention of RSV LRTD. Arexvy is approved for use in adults ≥50 years old. Abrysvo is approved for use in adults ≥60 years old and in pregnant women to prevent RSV LRTD in their infants.

The FDA has approved Shield (Guardant), a DNA blood test, for colorectal cancer (CRC) screening in average-risk adults ≥45 years old. Shield is the second blood-based DNA test to be approved for CRC screening; ColoHealth (formerly Epi proColon) was approved in 2016.

The thiazolidinediones rosiglitazone (Avandia) and pioglitazone (Actos) are peripheral insulin sensitizing agents used to treat hyperglycemia in patients with type 2 diabetes; one or the other is often used as a second or third agent with metformin (Glucophage, and others) and/or a sulfonylurea such as glimepiride (Amaryl, and others). A recent report suggested that rosiglitazone may increase the incidence of myocardial infarction (MI) and cardiovascular mortality.

Zoledronic acid (Reclast - Novartis) is the first bisphosphonate approved by the FDA for once-yearly intravenous (IV) treatment of osteoporosis in postmenopausal women. Reclast is also approved for treatment of Paget's disease. Another IV formulation of zoledronic acid (Zometa) is approved for treatment of hypercalcemia of malignancy, multiple myeloma and bone metastases from solid tumors.

Anticoagulants are the drugs of choice for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), collectively referred to as venous thromboembolism (VTE).