The FDA has approved the marketing of extended release (ER) ranolazine (Ranexa - CV Therapeutics) for treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs. It should be used in combination with a nitrate, a beta-blocker or the dihydropyridine calcium-channel blocker amlodipine (Norvasc), and appears to be more effective in men. The labeling for ranolazine specifies amlodipine as the calcium-channel blocker of choice because the use of other dihydropyridines with ranolazine has not been studied, and use with diltiazem (Cardizem, and...

The FDA has approved Exforge (Novartis) and Azor (Daiichi Sankyo), the first combinations of a calcium channel blocker (CCB) with an angiotensin receptor blocker (ARB) for treatment of hypertension. Amlodipine is the CCB in both products. The ARBs are valsartan in Exforge and olmesartan in Azor. All 3 of these drugs are available in fixed-dose combinations with other antihypertensive drugs.

Effective treatment of hypertension can prevent organ damage and death. The choice of drugs for initial treatment continues to be controversial.

Most patients with hypertension require more than one drug to control their blood pressure. Exforge HCT (Novartis) is a new 3-drug fixed-dose combination tablet approved by the FDA for treatment of hypertension. It combines the calcium-channel blocker amlodipine (Norvasc, and others) and the angiotensin receptor blocker (ARB) valsartan (Diovan), which are already available in a combination tablet (Exforge), with the most commonly prescribed diuretic hydrochlorothiazide (HCTZ). Exforge HCT is not approved for initial treatment of hypertension, but rather for patients not adequately controlled...

The FDA has approved Twynsta (Boehringer Ingelheim), a fixed-dose combination of the calcium-channel blocker (CCB) amlodipine and the angiotensin receptor blocker (ARB) telmisartan, for treatment of hypertension.

The FDA has approved use of denosumab (Prolia – Amgen) for treatment of osteoporosis in postmenopausal women at high risk for fracture.

Xywav (Jazz), an oral solution that contains calcium, magnesium, potassium, and sodium oxybates, has been approved by the FDA for treatment of idiopathic hypersomnia in adults. It is the first drug to be approved in the US for this indication. Xywav was approved in 2020 for treatment of excessive daytime sleepiness or cataplexy in patients ≥7 years old with narcolepsy. It contains about 92% less sodium than sodium oxybate oral solution (Xyrem), which has been available in the US for years for use in patients ≥7 years old with narcolepsy.

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.

Flecainide (Tambocor -3M Pharmaceuticals), first introduced in 1985 for treatment of ventricular arrhythmias, was recently approved by the US Food and Drug Administration for oral use to prevent supraventricular arrhythmias. The indications for using flecainide to treat ventricular arrhythmias were limited after a controlled trial found that post-myocardial infarction patients with asymptomatic ventricular arrhythmias who took the drug had twice as high a mortality rate as patients who took placebo (DS Echt et al, N Engl Med, 324:781, 1991).

Calcipotriene ointment 0.005% (calcipotriol; Dovonex - Westwood Squibb), a synthetic vitamin D 3 analog previously available in Europe and Canada, has now been approved by the US Food and Drug Administration (FDA) for treatment of moderate plaque psoriasis, the most common form of the disease.