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Pharmaceuticals / Submissions and Approvals

First Insulin ‘Follow-On’ Gets FDA Nod Under Abbreviated Approval

Dec. 18, 2017

The FDA approved Sanofi’s Admelog, the first short-acting insulin product cleared as a “follow-on.”

The agency approved the drug through its abbreviated 505(b)(2) approval pathway, which allows sponsors to cite findings that previously approved drugs are safe or effective to support the product’s safety or effectiveness.

In the case of Admelog, the manufacturer relied on the previous finding of safety and effectiveness for Humalog, an injectable insulin product. Admelog can be injected or administered via insulin pump or intravenous infusion.

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