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Sanofi's Admelog, a Humalog Follow-On, Approved In US As 'Black Hole' For Insulins Looms

Executive Summary

Short-acting insulin approved under 505(b)(2) pathway appears poised to receive three years of Hatch-Waxman exclusivity but would lose nine months of this protection under FDA's current interpretation of the 'transition provisions' for certain protein products that take effect in March 2020.

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