Antidepressant Manufacturers’ Trial Information Requested By Senate Cmte.
This article was originally published in The Pink Sheet Daily
Finance Chairman Grassley asks eight manufacturers for list of all pediatric antidepressant trials, including completion, publication and FDA submission information. Grassley expresses concern that the firms may not have provided FDA with all the information “at their disposal.”
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The congressman's letter requests the immediate release of data for drugs that gained six months of additional exclusivity under the Best Pharmaceuticals for Children Act. While seven companies have gained exclusivity extensions for antidepressants, data on only two are available, he says.
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