The FDA recently approved vandetanib [van det´ a nib] (Caprelsa – AstraZeneca) for oral treatment of symptomatic or progressive medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Vandetanib is the first drug approved in the US for medullary thyroid cancer.

The FDA has approved the use of nitroglycerin ointment 0.4% (Rectiv – ProStrakan/Aptalis) for treatment of moderate to severe pain associated with chronic anal fissure; the same drug is marketed as Rectogesic in Europe. Nitroglycerin ointment 2% (Nitro-Bid) is available in the US for prevention of angina.

An oral solution (Vituz – Hawthorne) containing two old drugs, the centrally-acting opioid hydrocodone bitartrate and the first-generation H1-antihistamine chlorpheniramine maleate, has been approved by the FDA for relief of cough and [other] symptoms associated with upper respiratory allergies or a common cold in adults. Several extended-release products containing hydrocodone and chlorpheniramine are available as capsules and suspensions and have been used for years for similar indications. Vituz is classified as a schedule III controlled substance, but the FDA has asked the DEA...

Metreleptin (Myalept – Amylin), a recombinant leptin analog produced in E. coli, has been approved by the FDA to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. It has not been approved to date for the treatment of partial lipodystrophies, including those associated with the use of protease inhibitors in patients with HIV. Metreleptin is approved in Japan for the treatment of any lipodystrophy disorder.

The FDA has approved filgrastim-sndz (Zarxio – Sandoz), a biosimilar of the recombinant human granulocyte colony-stimulating factor filgrastim (G-CSF; Neupogen), which has been available in the US since 1991. Zarxio is the first biosimilar product to be approved in the US; it has been available in Europe as Zarzio since 2009.

Rilonacept (Arcalyst – Kiniksa), an interleukin-1 (IL-1) antagonist that has been available for years for treatment of cryopyrin-associated periodic syndromes, has now been approved by the FDA for treatment of recurrent pericarditis and prevention of further recurrences in patients ≥12 years old. It is the first drug to be approved in the US for this indication. Anakinra (Kineret), an IL-1 receptor antagonist FDA-approved for treatment of rheumatoid arthritis, has been used off-label for years for treatment of recurrent pericarditis.

Xywav (Jazz), an oral solution that contains calcium, magnesium, potassium, and sodium oxybates, has been approved by the FDA for treatment of idiopathic hypersomnia in adults. It is the first drug to be approved in the US for this indication. Xywav was approved in 2020 for treatment of excessive daytime sleepiness or cataplexy in patients ≥7 years old with narcolepsy. It contains about 92% less sodium than sodium oxybate oral solution (Xyrem), which has been available in the US for years for use in patients ≥7 years old with narcolepsy.

The FDA has approved an over-the-counter (OTC) liquid-filled capsule formulation of aspirin (Vazalore – PLx Pharma). The manufacturer has been heavily promoting Vazalore with claims of fast, predictable absorption and antiplatelet activity and improved gastrointestinal safety compared to existing OTC aspirin formulations.

Vimseltinib (Romvimza – Deciphera), an oral kinase inhibitor, has been approved by the FDA for treatment of symptomatic tenosynovial giant cell tumor in adults for whom surgical resection would cause worsening functional limitation or severe morbidity. The kinase inhibitor pexidartinib (Turalio) was approved for a similar indication in 2019.

Mesalamine (Rowasa - Reid-Rowell), probably better known as 5-aminosalicylic acid (5-ASA) and also called mesalazine in some other countries, was recently marketed in the USA as an enema for treatment of mild to moderate distal ulcerative colitis, including ulcerative proctosigmoiditis and ulcerative proctitis.