Food and Drug Administration Update for Pediatric Practitioners

Marcia L. Buck, Pharm.D., FCCP


Pediatr Pharm. 2002;8(1) 

In This Article

New Drug Releases

On December 13, 2001, pimecrolimus 1% cream (Elidel®; Novartis) was approved by the FDA for the treatment of mild to moderate atopic dermatitis in patients two years of age and older. Like topical tacrolimus, this product selectively inhibits T-cell activation, blocking the production and release of cytokines. In clinical trials, reductions in itching and redness were seen within 8 days of starting treatment. The most frequently reported adverse effect in clinical trials was a transient feeling of warmth or burning. There is minimal systemic absorption after topical use. Pimecrolimus cream is available in 15, 30, and 100 gram tubes.[1]

Darbepoetin alfa (Aranesp®; Amgen) was approved by the FDA on September 18, 2001 for the treatment of anemia associated with chronic renal failure. With its longer half-life, darbepoetin can be given less frequently than traditional epoetin. It can be given once weekly (0.45 mcg/kg intravenously or subcutaneously) in patients who were receiving epoetin three times per week or every other week in patients who were receiving epoetin on a weekly schedule.[2] Darbepoetin was added to the UVA Formulary last month. While initially approved by the FDA only for adults, it is anticipated that this drug will have application in pediatric patients as well.

The FDA approved dexmethylphenidate (expected to go by the trade name Ritadex®) on November 13, 2001 for the management of attention deficit/hyperactivity disorder (ADHD). This product, a single isomer of methylphenidate, is a co-marketing venture from Novartis, the maker of Ritalin®, and the Celgene Corporation. Methylphenidate has previously only been available as a racemic mixture. It is hoped that the new product will allow better dose titration to minimize adverse effects. Dexmethylphenidate comes in 2.5, 5, and 10 mg tablet strengths.[3]


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