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Pediatric Advisory Committ

September 15

The committee will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155).

The committee will meet to discuss the following products (listed by FDA Center):

(1) Center for Biologics Evaluation and Research

  1. GAMUNEX®-C (immune globulin intravenous (human)), 10%, Caprylate/Chromatography Purified

(2) Center for Devices and Radiological Health

  1. FLOURISH™ Pediatric Esophageal Atresia Device (humanitarian device exemption)

(3) Center for Drug Evaluation and Research

  1. ADZENYS ER (amphetamine) extended-release oral suspension,
  2. MYDAYIS (mixed salts of a single-entity amphetamine product) extendedrelease

capsule, for oral use,

  1. ORENCIA (abatacept) for injection, for intravenous use
  2. VYVANSE® (lisdexamfetamine dimesylate) capsule and chewable tablet,

FDA will discuss acute dystonia associated with the use of attention deficit hyperactivity disorder (ADHD) medications (including methylphenidate products, amphetamine products, and atomoxetine). Additionally, FDA will discuss acute hyperkinetic movement disorder associated with the combined use of ADHD stimulants and antipsychotics (including first-generation antipsychotics and second-generation antipsychotics).


September 15
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