FDA Claritin Hypospadia Review Targeted For Summer Completion
This article was originally published in The Tan Sheet
Executive Summary
FDA's review of safety and birth registry data to determine whether Schering-Plough's Claritin (loratadine) could be linked to hypospadia is expected to take approximately three months
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Schering-Plough's post-approval commitments for OTC Claritin include submitting to FDA reported cases of the birth defect hypospadia following maternal ingestion of loratadine, the company said