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Allergan’s Manufacturing Challenges Produce Second Levadex “Complete Response” Letter

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA again cites inspection issues related to a third-party facility where the product canister for the migraine drug is manufactured, as well as the manufacturing process itself; Allergan says it recently completed an acquisition of that third-party firm, thereby bringing the inhaled treatment’s manufacturing in-house.

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