Shire's positive topline data from a pediatric Phase III trial of SHP465 (triple-bead mixed amphetamine salts) addresses the US FDA requirements for a class 2 resubmission for the product's NDA, said the company. The product is slated for US launch in 2017.
Shire now has a database of 15 clinical studies evaluating SHP465 in more than 1,100 subjects. Once the pharmacokinetic study...
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