An Approval 30 Years In The Making: FDA Re-Approves Morning Sickness Drug
This article was originally published in The Pink Sheet Daily
Canadian-based Duchesnay’s Diclegis has the same active ingredients as Bendectin, which was withdrawn in 1983 in the wake of litigation; FDA says epidemiological studies have shown the combination of drug ingredients does not pose an increased risk of harm to the fetus.
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Neither has announced a firm timeline, and the difference between Pfizer's 'October' and Moderna's 'November' could be mere hours or a few weeks, but Pfizer, by dint of luck or experience, is now in a position to offer the more optimistic projection on when it will seek an EUA. Both firms release their Phase III trial protocols, which seem in line with US FDA guidance.