Allergan Manufacturing Headaches Continue For Semprana
This article was originally published in The Pink Sheet Daily
Inhalable acute migraine drug previously known as Levadex receives third “complete response” letter from FDA.
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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 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.
Pfizer's biosimilar franchise is well on its way to becoming a blockbuster business three years after the company launched its first US biosimilar.