The FDA has approved cariprazine (Vraylar – Actavis), an oral, once-daily, second-generation antipsychotic, for treatment of schizophrenia and for acute treatment of manic or mixed episodes associated with bipolar I disorder.

The FDA has warned that use of an SGLT2 (sodium-glucose co-transporter 2) inhibitor for treatment of type 2 diabetes may lead to ketoacidosis.1 Three SGLT2 inhibitors, canagliflozin (Invokana, Invokamet), dapagliflozin (Farxiga, Xigduo XR), and empagliflozin (Jardiance, Glyxambi), are approved for treatment of type 2 diabetes in the US. Between March 2013 and June 2014, 20 cases of ketoacidosis requiring emergency room visits or hospitalization were reported in patients who had recently started taking an SGLT2 inhibitor; the median time to onset of symptoms after initiation of therapy was 2...

The FDA has approved oral cholic acid (Cholbam – Retrophin) for treatment of children and adults with bile acid synthesis disorders caused by single enzyme defects and for adjunctive treatment of peroxisomal disorders such as Zellweger spectrum disorders in patients who have liver disease, steatorrhea, or complications from fat-soluble vitamin malabsorption. Patients with these rare inborn errors of bile acid metabolism cannot synthesize primary bile acids such as cholic acid, resulting in reduced bile flow, decreased absorption of fat and fat-soluble vitamins, and development of liver...

The FDA recently announced changes in the labeling of the hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) to warn about a risk of serious and potentially fatal bradycardia when either drug is taken with the antiarrhythmic drug amiodarone (Cordarone, and others).1 Symptomatic bradycardia was reported following initiation of treatment with Harvoni or with Sovaldi plus simeprevir (Olysio) or the investigational antiviral drug daclatasvir in 9 patients already taking amiodarone; it occurred within 24 hours of starting hepatitis C therapy in 6 patients and within 2-12...

Nizatidine (Axid - Lilly), a new H2-receptor antagonist similar to cimetidine (Tagamet), ranitidine (Zantac) and famotidine (Pepcid), was recently approved by the US Food and Drug Administration for treatment of active duodenal ulcer and for maintenance therapy after healing. Cimetidine, ranitidine and famotidine are also approved for treatment of pathological hypersecretory conditions such as Zollinger- Ellison syndrome; cimetidine is approved in addition for treatment of gastric ulcers.

Betaxolol (Kerlone - Searle), an oral beta-adrenergic blocker, was recently approved by the US Food and Drug Administration for once-daily treatment of hypertension. The new drug is beta 1 (cardio)-selective with no intrinsic sympathomimetic (partial agonist) activity. It is also available in a topical formulation for treatment of glaucoma (Betoptic - Medical Letter, 28:45, 1986). Beta-blockers currently available in the USA for treatment of hypertension are listed in the table below.

Amlodipine (am loe' di peen) besylate (Norvasc - Pfizer), a dihydropyridine calcium-channel blocker, has been approved by the US Food and Drug Administration for once-daily oral treatment of hypertension, chronic stable angina, and vasospastic (Prinzmetal's) angina.

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.

Losartan potassium (Cozaar - Merck), the first angiotensin II receptor antagonist, has been approved for oral treatment of hypertension by the US Food and Drug Administration. It will be marketed both alone and in a fixed-dose combination with the diuretic hydrochlorothiazide (Hyzaar).