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U.S. Department of Health and Human Services

Safety

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Aerospan (flunisolilde) Inhalation Aerosol

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2013

Summary View

 

USE IN SPECIAL POPULATIONS

Pediatric Use
Effects on Growth
  • The potential effect of Aerospan on growth rates in children was assessed in a 52 week randomized, placebo controlled study conducted in 242 prepubescent children age 4 to 9.5 years (145 males, 97 females) with mild persistent asthma…