FDA Needs More Pediatric Data For Resubmission Of ADHD Drug: Shire
Irish drug company Shire Plc. (SHP.L,SHPG: Quote) said the U.S. Food and Drug Administration or FDA has now clarified that additional pediatric data would be required for SHP 465 or triple-bead mixed amphetamine salts MAS, an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder or ADHD in adults.
Shire stated that the information will impact its plans for a 2014 New Drug Application or NDA resubmission for SHP 465.
On April 25, 2014, in written correspondence, the FDA responded to Shire's resubmission proposal package confirming that Shire could submit SHP 465 as a Class 2 resubmission.
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Shire stated that the information will impact its plans for a 2014 New Drug Application or NDA resubmission for SHP 465.
On April 25, 2014, in written correspondence, the FDA responded to Shire's resubmission proposal package confirming that Shire could submit SHP 465 as a Class 2 resubmission.
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