Mobocertinib (Exkivity – Takeda), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy. Accelerated approval was based on the overall response rate and duration of response. Mobocertinib is the second drug to become available in the US for this indication; the IV EGFR-MET bispecific antibody amivantamab (Rybrevant) was approved...

The FDA has approved Rebyota (Ferring), a rectally-administered, live fecal microbiota suspension, for prevention of additional recurrences of Clostridioides difficile infection (CDI) following antibiotic treatment for a recurrent episode of CDI in adults. Rebyota is the first microbiome-based treatment to be approved for this indication. It is not approved for initial treatment of CDI. Fecal microbiota transplantation (FMT) has been used in patients with multiple CDI recurrences.

The FDA recently issued a Drug Safety Communication saying that it had asked the manufacturer of ponatinib (Iclusig – Ariad) to suspend marketing and sales of the drug because of the risk of life-threatening blood clots and severe narrowing of blood vessels.1 Ponatinib is a tyrosine kinase inhibitor that was granted accelerated approval by the FDA in December 2012 for treatment of chronic-, accelerated, or blast-phase chronic myeloid leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) resistant to (or the patients were intolerant to) prior tyrosine...

The FDA has required labeling changes that replace serum creatinine (SCr) with estimated glomerular filtration rate (eGFR) as the parameter used to determine the appropriateness of treatment with the biguanide metformin (Glucophage, and others) in patients with renal impairment. These changes will allow more patients with mild to moderate renal impairment to receive metformin, which is generally the first drug prescribed for treatment of type 2 diabetes.Metformin was previously contraindicated in women with a SCr level ≥1.4 mg/dL and in men with a SCr level ≥1.5 mg/dL, but use of SCr as a...

The FDA has approved Byvalson (Allergan), a fixed-dose combination of the beta blocker nebivolol (Bystolic) and the angiotensin receptor blocker (ARB) valsartan (Diovan, and generics), for treatment of hypertension. It is the only combination product that contains nebivolol, and the first to combine a beta blocker with an ARB.

Epoprostenol sodium (Flolan - Glaxo Wellcome), also known as prostacyclin, has been approved by the US Food and Drug Administration for continuous intravenous treatment of primary pulmonary hypertension.

The FDA has asked the manufacturers of the selective serotonin reuptake inhibitor (SSRI) antidepressant citalopram (Celexa, and others) to revise the labeling of the drug to include new warnings about the risk of QT interval prolongation.

Management of intermittent claudication, the most common symptom of peripheral arterial disease (PAD), involves both risk factor modification and symptomatic treatment (WR Hiatt, N Engl J Med 2001; 344:1608; RM Schainfeld, J Am Board Fam Pract 2001; 14:443).

Perindopril, the tenth angiotensin converting enzyme (ACE) inhibitor to be marketed in the USA, and telmisartan and eprosartan, the fifth and sixth angiotensin receptor blockers, have recently become available for treatment of hypertension.

The FDA has approved patiromer (Veltassa – Relypsa), an oral potassium binder, for treatment of hyperkalemia. It is the first drug to be approved for this indication since the cation-exchange resin sodium polystyrene sulfonate (Kayexalate, and others) in 1958. Patiromer is not indicated for emergency correction of life-threatening hyperkalemia. Sodium zirconium cyclosilicate, another oral potassium binder, is currently being reviewed by the FDA; a decision on its approval is expected in May 2016.