The FDA has approved Onyda XR (Tris), an extended-release (ER) oral suspension formulation of the alpha_2-adrenergic agonist clonidine, for use as monotherapy or as an adjunct to stimulant therapy for treatment of attention-deficit/hyperactivity disorder (ADHD) in children ≥6 years old. Clonidine ER tablets have been available for years for treatment of ADHD in children 6-17 years old.

The FDA has approved Vybrique (IBSA), an oral film formulation of the phosphodiesterase type 5 (PDE5) inhibitor sildenafil, for treatment of erectile dysfunction (ED). Sildenafil oral tablets (Viagra, and generics) have been available since 1998. The manufacturer is promoting the new product as a "discreet, on-the-go" option that can be taken without water.

Dordaviprone (Modeyso – Jazz), an oral protease activator, has received accelerated approval from the FDA for treatment of diffuse midline gliomas harboring a H3 K27M mutation in patients ≥ year old who had disease progression following prior treatment. It is the first drug to be approved in the US for this indication.

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.

View the Comparison Table: Triptans for Migraine

Colchicine (Colcrys, and others), which has been available in the US for decades for prophylaxis and treatment of gout flares and other indications in oral formulations that contain 0.6 mg of the drug, has now been approved in 0.5-mg tablets as Lodoco (Agepha) to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adults with established atherosclerotic disease or multiple risk factors for cardiovascular disease.

The FDA has approved Crexont (Amneal), an extended-release capsule formulation of carbidopa/levodopa, for treatment of Parkinson's disease (PD), postencephalitic parkinsonism, and parkinsonism associated with carbon monoxide or manganese intoxication. Crexont contains a combination of immediate-release carbidopa/levodopa granules and extended-release levodopa pellets. An extended-release carbidopa/levodopa oral capsule (Rytary) has been available from the same manufacturer for years; the patent for Rytary expires in 2025.

The FDA has approved diazoxide choline extended-release tablets (Vykat XR – Soleno Therapeutics) for treatment of hyperphagia in patients ≥4 years old with Prader-Willi syndrome. Diazoxide choline is the first drug to be approved in the US for this indication. Diazoxide oral suspension (Proglycem) has been available for years for management of symptomatic hypoglycemia.

Relacorilant (Lifyorli – Corcept Therapeutics), an oral first-in-class glucocorticoid receptor antagonist, has been approved by the FDA for use in combination with nab-paclitaxel (Abraxane, and generics) for treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who received 1-3 prior lines of systemic therapy, one of which included bevacizumab (Avastin, and others).

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali – Novartis), which was approved by the FDA in 2017 for use with an aromatase inhibitor or fulvestrant for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, has now been approved for use with an aromatase inhibitor for adjuvant treatment of HR-positive, HER2-negative stage II or III early breast cancer at high risk of recurrence. Kisqali can be used in patients with node-positive or node-negative disease. The CDK 4/6...