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.
You may also be interested in...
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.
Metsera Launches As New Obesity Contender Flush With $290m
Clive Meanwell, former CEO of The Medicines Company, will helm the new company, backed by ARCH and other investors. He talked to Scrip about the new venture.