The FDA has approved donislecel-jujn (Lantidra – CellTrans), an allogeneic pancreatic islet cellular therapy, for use in conjunction with immunosuppression for treatment of adults with type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Donislecel is the first cell-based treatment to be approved in the US for type 1 diabetes.

Resmetirom (Rezdiffra – Madrigal), a thyroid hormone receptor-beta agonist, has received accelerated approval from the FDA for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced fibrosis in adults. NASH has recently been renamed metabolic dysfunction-associated steatohepatitis (MASH). Resmetirom is the first drug to be approved in the US for this indication.

Aliskiren (ah LIS ker in; Tekturna - Novartis), the first direct renin inhibitor, has been approved by the FDA for treatment of hypertension. It is indicated for oral use either as monotherapy or in combination with other antihypertensive agents.

Fluticasone furoate nasal spray (Veramyst - GSK) is now available for once-daily treatment of seasonal and perennial allergic rhinitis in adults and children ≥2 years old. It is similar to fluticasone propionate nasal spray (Flonase, and others), which is now available generically.

Acne is common among adolescents and adults. Guidelines for treatment of acne were last published by the American Academy of Dermatology in 2016.

Production of erythropoietin, a glycoprotein hormone secreted mainly by the kidney, is often low in patients with chronic renal failure (JW Eschbach, Kidney Int, 35:134, 1989). The US Food and Drug Administration recently approved marketing of epoetin alfa (Epogen - Amgen), a recombinant human erythropoietin, for treatment of anemia in such patients. Epoetin is commercially available in Europe as Eprex (Ortho), and Eprex is available from Ortho in the USA on an investigational basis for treatment of anemia related to AIDS. Epogen and Eprex are chemically...

Felbamate (Felbatol - Wallace Laboratories), a phenyl dicarbamate structurally similar to meprobamate (Equanil, and others), was recently approved by the US Food and Drug Administration for use alone or with other drugs in adults with partial seizures with or without secondary generalization. It was also approved for use in addition to other drugs in children with the multiple types of seizures associated with the Lennox-Gastaut syndrome, a severe epileptic encephalopathy.

Lamotrigine (la mo tri jeen; Lamictal - Burroughs Wellcome), a phenyltriazine derivative, has been approved by the US Food and Drug Administration for use in addition to other antiepileptic drugs in adults with partial seizures. Since this diagnostic category includes the largest number of patients with intractable epilepsy, new drugs with antiepileptic activity are usually tried first for this indication. Lamotrigine was first marketed abroad in 1990 and is now available in more than 50 other countries.

A live attenuated varicella vaccine (Varivax - Merck) has been approved for marketing by the US Food and Drug Administration. The Oka/Merck strain used in the vaccine is attenuated by passage in human and embryonic guinea pig cell cultures.

Cerivastatin (Baycol - Bayer), a new HMG-CoA reductase inhibitor (or "statin"), has been approved by the FDA for treatment of hypercholesterolemia. Cerivastatin is the sodium salt of a synthetic fluorophenyl pyridinyl-substituted heptanoic acid.