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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  04/14/2009
 
Trade Name:  Suprane
 
Generic Name or Proper Name (*):  desflurane
 
Indications Studied:  Safety study of 2 agents used for maintenance of anesthesia in non-intubated patients
 
Label Changes Summary:  * Postmarketing Reports subsection added to the Adverse Events section of labeling, including reports of cardiac disorders. * Postmarketing reports are voluntary; it is not possible to estimate frequency or causality to drug exposure.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Baxter
 
Pediatric Exclusivity Granted Date:  09/13/2006
 
NNPS:  TRUE
 
Therapeutic Category:  Anesthetic agent
 
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