Food and Drug Administration Update for Pediatric Practitioners

Marcia L. Buck, Pharm.D., FCCP


Pediatr Pharm. 2002;8(1) 

In This Article

New Dosage Formulations


On October 12, 2001, Shire Pharmaceuticals received approval to market an extended release preparation of Adderall®, its widely-used amphetamine/dextroamphetamine product for the treatment of ADHD. A single morning dose is designed to provide effective symptom control throughout the entire school day. Adderall XR® is available as 10, 20, and 30 mg capsules.[4]

A new amoxicillin/clavulanate preparation, Augmentin ES-600® (GlaxoSmithKline), was approved by the FDA on November 6, 2001 for children 3 months of age or older with recurrent or persistent acute otitis media. The product, an oral suspension, contains 600 mg amoxicillin and 42.9 mg clavulanate per 5 ml. It has been designed to facilitate a high-dose amoxicillin regimen (90 mg/kg/day divided into two doses) without providing excessive clavulanic acid.[5]

An orally administered formulation of budesonide (Entocort EC®; AstraZeneca) has been approved by the FDA for the treatment of mild to moderate active Crohn's disease. This formulation releases drug into the intestine, where it works locally to decrease inflammation. Entocort EC® has been shown to provide the same degree of improvement in symptoms as oral prednisone or prednisolone, but with fewer systemic adverse effects. It is currently approved only for adults, but will likely also be used in younger patients in order to minimize steroid-associated growth impairment.[6]

Dey Labs has received approval from the FDA to market their new albuterol product, AccuNeb®, for use in children between 2 and 12 years of age. The product is available in 1.25 mg/3 ml and 0.63 mg/3 ml concentrations for nebulization without further dilution. It is a sterile, preservative-free solution and does not contain benzalkonium chloride. This is the first albuterol product designed for younger patients.[7]


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