The FDA has approved vonoprazan (Voquezna – Phathom), a potassium-competitive acid blocker, for healing and maintenance of healing of all grades of erosive esophagitis and relief of associated heartburn in adults. Vonoprazan is also available copackaged with amoxicillin (Voquezna Dual Pak) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection in adults.

The FDA has approved an oral extended-release formulation of gepirone (Exxua – Fabre-Kramer), a selective 5-HT_1A receptor agonist, for treatment of major depressive disorder (MDD) in adults. Gepirone was originally developed decades ago for treatment of anxiety and depression, but it was not approved by the FDA for such use. Gepirone is structurally related to buspirone, which is FDA-approved for treatment of anxiety.

View the Comparison Table: Some Oral Antiseizure Medications

Glycopyrrolate (Robinul, and others), a synthetic muscarinic receptor antagonist, has been used off-label for many years for treatment of excessive drooling in patients with Parkinson’s disease, in patients taking clozapine for schizophrenia, and in developmentally disabled children.1-3 It has now been approved by the FDA as Cuvposa (Shionogi) for use specifically in children 3-16 years old with severe chronic drooling due to a neurologic condition, such as cerebral palsy. It is being marketed as an oral solution, which will permit more precise weight-based dosing than was possible with the...

The CDC recently announced that it will now supply the investigational drug miltefosine (Impavido – Paladin, Canada) for treatment of infections caused by free-living amebae.1 The drug was previously available in the US only from the manufacturer through an FDA Investigational New Drug (IND) application.Meningoencephalitis caused by the free-living amebae Naegleria fowleri, Acanthamoeba spp., or Balamuthia mandrillaris, usually acquired through the nose while swimming in warm fresh water, has a mortality rate of >90% despite treatment with multiple antimicrobial drugs.2 Miltefosine is...

The FDA has removed the requirement that mifepristone (Mifeprex, and generics), a progestin receptor antagonist approved for use in a regimen with the prostaglandin E1 analog misoprostol (Cytotec, and generics) for medical termination of pregnancy, must be dispensed in person to the patient.

The FDA has required a new warning in the label for the scopolamine transdermal patch (Transderm-Scōp, and generics) about a risk of serious or fatal hyperthermia. Scopolamine, an anticholinergic drug, is FDA-approved for prevention of nausea and vomiting associated with motion sickness or recovery after surgery in adults; it is often used off-label to reduce drooling in children and adolescents with neurologic disorders.

Alzheimer's disease (AD) is the most common cause of dementia, but cognitive decline also occurs in other neurological conditions, such as Parkinson's disease, Lewy body dementia, vascular dementia, and frontotemporal dementia.

The US Food and Drug Administration recently approved ''Treatment IND';'; (investigational new drug) protocols for Exosurf (Burroughs Wellcome) and Survanta (Ross), two preparations of surfactant used for prevention and treatment of the respiratory distress syndrome (RDS) in premature newborn infants. Consequently, these drugs will be available to virtually every level-ΙΙΙ neonatal intensive-care unit in the USA.

Isradipine (DynaCirc - Sandoz), a dihydropyridine calcium-channel blocker chemically related to nicardipine (Cardene) and nifedipine (Procardia, and others), was recently approved by the US Food and Drug Administration for oral treatment of hypertension.