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Allergan Manufacturing Headaches Continue For Semprana

This article was originally published in Pharmaceutical Approvals Monthly

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

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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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