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).

The FDA has approved marketing of the corticosteroid budesonide in an oral inhalatoin powder formulation (Pulmicort Turbuhaler - Astra) for maintenance treatment of asthma in adults and children at least six years old. Budesonide has been available in the USA as an intranasal spray (Rhinocort) for treatment of allergic rhinitis since 1994 and has been used for inhalation treatment of asthma in Canada and Europe for ten years.

Repaglinide (Prandin - Novo Nordisk) is a new oral glucose-lowering agent for treating type 2 diabetes (formerly called non-insulin-dependent diabetes mellitus or NIDDM). It has been approved by the FDA for monotherapy or for use in combination with metformin.