Regorafenib (Stivarga – Bayer), a multikinase inhibitor, has been approved by the FDA for treatment of patients with metastatic colorectal cancer previously treated with multiple other regimens specified in the labeling. It has also been approved for use in treatment-refractory, locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST).

The FDA has approved crizotinib (Xalkori – Pfizer), an oral tyrosine kinase inhibitor, for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with the anaplastic lymphoma kinase (ALK) translocation, which is found in about 4-5% of lung cancers. A diagnostic test (Vysis ALK Break Apart FISH Probe Kit – Abbott Molecular) is available to detect translocations of the ALK gene in tumor samples; these translocations occur predominantly in nonsmokers with adenocarcinoma.

Almotriptan (Axert - Pharmacia), and Frovatriptan (Frova - Elan) have been approved by the FDA for oral treatment of migraine headache (Drugs of Choice from The Medical Letter 2001, page 131.).

The FDA has approved use of tadalafil (Adcirca - Lilly/United Therapeutics) for treatment of pulmonary arterial hypertension (PAH).

The FDA has approved vonoprazan, a potassium-competitive acid blocker, copackaged with amoxicillin (Voquezna Dual Pak – Phathom) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection in adults. Vonoprazan is the first potassium-competitive acid blocker to be approved in the US. It has been available in Japan for treatment of various acid-related disorders since 2014. Vonoprazan is not available alone in the US.

On December 22, 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug nirmatrelvir copackaged with the HIV-1 protease inhibitor ritonavir (Paxlovid – Pfizer) for oral treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh at least 40 kg and are at high risk of progressing to severe disease, including hospitalization or death. Paxlovid was the first oral antiviral drug to be authorized in the US for treatment of COVID-19; Merck's oral antiviral drug molnupiravir was granted an EUA for treatment of COVID-19 on...

Full-page newspaper advertisements are urging patients with high cholesterol levels who are stopping Baycol (cerivastatin) to ask their doctors about Pravachol (pravastatin), Lipitor (atorvastatin), Zocor (simvastatin) or Lescol (fluvastatin). Some advertisements come with a coupon for free medication. Lovastatin, which is available generically, has not appeared in similar advertisements. Cerivastatin was withdrawn from the market on August 8 because of post-marketing reports of 31 cases of fatal rhabdomyolysis.

The FDA has approved vorapaxar (Zontivity – Merck), an oral protease-activated receptor-1 (PAR-1) antagonist, for use with aspirin and/or clopidogrel to reduce the risk of thrombotic cardiovascular events in patients with peripheral arterial disease or a history of myocardial infarction (MI). It is the first PAR-1 antagonist to be approved by the FDA.

Zolmitriptan (Zomig - Zeneca), a selective serotonin (5-HT1)-receptor agonist, is now available in the USA for oral treatment of migraine headache. Zomitriptan structurally resembles sumatriptan (Imitrex - Medical Letter 34:91, 1992). Drugs currently used for acute treatment of migraine include injectable, oral and nasal spray formulations of sumaptriptan, injectable dihydroergotamine, dihydroergotamine nasal spray, ergotamine tartrate alone or with caffeine, and various analgesics. Anoterh 5-HT1-receptor agonist, naratriptan (Amerge - Gaxo Wellcome), has been approved by the FDA but has not...

Celecoxib, a selective COX-2 inhibitor, has been approved by the FDA for treatment of osteoarthritis and rheumatoid arthritis.