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Allergan Manufacturing Headaches Continue For Semprana

This article was originally published in The Pink Sheet Daily

Executive Summary

Inhalable acute migraine drug previously known as Levadex receives third “complete response” letter from FDA.

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

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.

Allergan Buys MAP To Chart Migraine Franchise Growth

Allergan partnered with MAP in 2011 for rights to commercialize Levadex for acute migraine in North America, but now will control 100% of the product’s revenue, creating a complementary product to Botox in chronic migraine. Levadex has an April 15 PDUFA date at FDA.

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