Allergan Inc. chalked up a third FDA complete response letter (CRL) regarding Semprana (dihydroergotamine), the orally inhaled acute migraine treatment formerly known as Levadex, and the heart of its $958 million acquisition of MAP Pharmaceuticals Inc. While the company may have existing data to address the manufacturing issues raised in the letter, it estimated the setback will delay further FDA action until the second quarter of 2015.
"As you know, manufacturing these days is getting tougher," said Scott Whitcup, Allergan's executive vice president of R&D and chief scientific officer, during a Monday investors call. "When we acquired the product and took over the manufacturing plant, we actually re-engineered the manufacturing process so that it's more robust."
The FDA acknowledged Allergan's improvement in the most recent CRL, noting the company had bettered its process for filling the canister, a key component of the Tempo inhaler