The FDA has approved the marketing of another extended-release brand-name formulation of the serotonin and norepinephrine reuptake inhibitor (SNRI) desvenlafaxine (Khedezla – Par/Osmotica) for treatment of depression. It is the third extended-release formulation of desvenlafaxine to become available in the US. Khedezla was approved using a 505(b)(2) application, a new drug application (NDA) that relies upon the FDA's findings of safety and/or effectiveness for a previously approved drug.Khedezla does not appear to offer any advantage over the other extended-release formulations of...

Lisdexamfetamine dimesylate (Vyvanse), a prodrug of dextroamphetamine previously approved for treatment of attention-deficit/hyperactivity disorder, has now been approved for treatment of moderate-to-severe binge eating disorder (recurrent episodes of compulsive overeating without purging) in adults.FDA approval of lisdexamfetamine for this indication was based on two unpublished, 12-week trials, summarized in the package insert, that randomized patients with moderate-to-severe binge eating disorder to lisdexamfetamine 30 mg/day, which was titrated to 50 mg or, if needed, 70 mg, or to placebo....

IV antiviral drug remdesivir (Veklury) has now been FDA-approved for treatment of COVID-19 in patients ≥28 days old who weigh ≥3 kg and are either hospitalized or at high risk for progression to severe disease. Remdesivir was already FDA-approved for these indications in patients ≥12 years old who weigh ≥40 kg; it was available under an Emergency Use Authorization (EUA) for younger or lighter patients. Remdesivir is the first drug to be FDA-approved for treatment of COVID-19 in children <12 years old.

Gamma hydroxy butyrate (GHB) sold in health food stores has recently caused outbreaks of gastrointestinal illness, central-nervous-system (CNS) depression, and seizures.

The FDA has approved the marketing of RotaShield, a live oral vaccine for prevention of infantile rotavirus infection. Rotaviruses are segmented double-stranded RNA viruses that are the most common cause of severe diarrhea and dehydration in infants and young children.

The results of a recently published study suggest that taking the oral direct thrombin inhibitor dabigatran etexilate (Pradaxa) with either simvastatin (Zocor, and others) or lovastatin (Altoprev, and others) increases the risk of major hemorrhage.

Ziac (Lederle), a combination of the beta-blocker bisoprolol fumarate and a very low dose (6.25 mg) of the diuretic hydrochlorothiazide, has been approved for treatment of hypertension by the US Food and Drug Administration (FDA). Bisoprolol, a new cardioselective beta-blocker with no intrinsic sympathomimetic activity, has also been marketed as a single drug (Zebeta - Lederle). The manufacturer is promoting the combination for initial treatment of hypertension with the claim that the low doses of the two drugs used together are effective in lowering blood pressure, but are each too low ...

Torsemide, a new loop diuretic similar in action to bumetanide (Bumex) and furosemide, was recently approved by the US Food and Drug Administration for treatment of edema due to congestive heart failure, renal disease, or hepatic disease and also for treatment of hypertension. It is available for both oral and intravenous use.

The US Food and Drug Administration has approved the marketing of 5% doxepin hydrochloride cream (Zonalon - GenDerm) for treatment of pruritus due to eczematous dermatoses. Oral doxepin is used as a tricyclic antidepressant (Sinequan, and others).

Tegaserod maleate (Zelnorm – Novartis), a partial serotonin 5-HT4 receptor agonist that increases gastrointestinal motility, was approved by the FDA in 2002 for short-term treatment of constipation-predominant irritable bowel syndrome in women,1 and in 2004 for treatment of chronic constipation in adults ≤65 years old. Its efficacy has not been impressive statistically, but according to Medical Letter consultants some patients with slow-transit constipation have benefited from taking the drug. Diarrhea has been its main adverse effect.2The FDA now has requested that the manufacturer stop...